NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.
Minnesota Health Technology Advisory Committee. Minnesota Health Technology Assessments [Internet]. St. Paul (MN): Minnesota Department of Health; 1995-2001.
This publication is provided for historical reference only and the information may be out of date.
Introduction
The Health Technology Advisory Committee (HTAC) was established by the Minnesota Legislature in 1992. HTAC provides objective, science-based assessments of selected health technologies and other information to policy makers, health care consumers, providers and others. All HTAC meetings are open to the public, and we welcome your inquiries and comments.
Universal newborn hearing testing was selected for study by HTAC based on several criteria, including: anticipated interest by the Minnesota Legislature and the broader community; the large number of persons potentially affected (all newborns, their parents, providers, and others); and questions regarding clinical effectiveness, costs, and cost-effectiveness of screening. In addition, federal law requires that all states provide intervention and educational assistance to children with disabilities, including those with hearing loss, beginning at birth to six years of age. To comply with this mandate, 15 states and the District of Columbia are screening all neonates for hearing loss shortly after birth and before hospital discharge.
This report has been prepared with the assistance of the HTAC Newborn Hearing Screening work group, staff, consultants, and other interested groups and individuals.
Background
A. Hearing Loss in Infants
1. Rates of hearing loss and the number of infants born each year with hearing loss
Robinette and White cite a number of prevalence studies of newborn hearing loss which report ranges from 1 per 1000 live births to 6 per 1000 live births. 1 Prevalence rates vary because of such factors as: inadequate sample size; vague hearing loss criteria; use of retrospective studies; and events such as measles outbreaks in pregnant women which may lead to newborn hearing loss. According to the researchers, the "average prevalence" for mild or greater congenitally acquired sensorineural hearing loss is 3 to 4 per 1000 live births. 1 An "average prevalence" of 3 hearing impaired newborns per 1000 live births would result in 192 hearing impaired neonates from among the estimated 64,000 live births annually in Minnesota. Prevalence rates are substantially higher among infants requiring care in a neonatal intensive care unit (NICU), where an estimated 1 in 60 infants are hearing impaired. 2 It has been estimated that of the nearly four million infants born in the United States each year, approximately 4,000 will be born profoundly deaf, and another 37,000 are born with milder hearing impairments. 3
2. The impact of early hearing loss
Bess and Paradise have asserted that "no dispute exists as to whether early childhood hearing loss can impose burdens on the affected child, on the child's family, and on society." 4 The United States Department of Health and Human Services (USDHHS) also concluded in its 1990 report on national public health goals for the year 2000, Healthy People 2000, that "disability due to hearing impairment is far reaching and can affect many aspects of life." 5
Communication is crucial to learning, socialization, and self-concept. Early hearing loss among infants is particularly significant because it interferes with normal speech and language development essential to communication. 4
The personal and social impacts of hearing loss are profound. People with hearing impairment "often have less desirable jobs and housing and incomes than people without hearing impairment." 5 Lifetime costs of each case of congenital deafness have been estimated at over $1 million, 4 and "programs and services for the communicatively handicapped are estimated to cost $23.4 billion per year in the United States." 6 Costs of lost earnings to people resulting from the disability caused by hearing loss was estimated to be over $1.25 billion annually in 1990. 5 Other burdens arise because of "emotional stress, breakdowns in family communication, and isolation of hearing impaired persons from peers and educational systems." 4
B. Newborn Hearing Testing
1. The need for early identification of hearing loss
Crucial speech and language development begins during the first six months after birth 8 and is crucial to development of communication. Therefore, "early detection and intervention are critical in reducing functional limitation and disability due to hearing impairment," and are "particularly important" in infants. 5
2. Screening versus diagnosis
Newborn screening is part of a continuum of care that includes diagnosis and treatment. In examining the issue of newborn hearing screening, it is important to distinguish between screening and diagnosis. A screening test attempts to find a condition or disease in subjects who appear healthy. Diagnosis is the confirmation that the condition actually is present (or absent), and is used in determining treatment options. This report addresses issues of initial screening, which may lead to further diagnosis. Some hearing screening tests may also subsequently be useful in diagnosing hearing loss.
3. Methods of hearing screening
Until relatively recently, the standard hearing test was "behavioral assessment." Under this technique, the infant would be subjected to a sound while observers watched for a reaction from the baby in response to it (i.e., testing an infant's "startle response"). The method is often limited by the observer's ability to subjectively assess the infant's reaction to the sound at the time of the test. 7
Over the last two decades, increasingly more sophisticated measures have been devised and used to measure physiologic changes in the baby arising in response to sound. Two primary methods are now used to check newborn hearing. Auditory brainstem response (ABR) uses electrodes placed on the infant's head to measure brain-wave responses to clicks administered to the ear. Variants of otoacoustic emission (OAE) testing use a probe placed within the infant's ear to measure inner-ear responses to sound. 7 These methods are more accurate for infants under 6 months of age than behavioral assessment. 8 The table below briefly summarizes the forms of ABR and OAE testing currently in use.
All of the tests described above are safe and non-invasive. 7 Some skin abrasions from the electrodes are the only complications associated with ABR and AABR; no complications are reported for TEOAE or DPOAE.
4. Additional considerations in screening
a) Screening of only high risk neonates
The auditory brainstem response (ABR) test became available prior to the availability of otoacoustic emission (OAE) testing, and remains in use. ABR is more time consuming and expensive than OAE, and therefore its application has generally been limited to detecting hearing loss in neonates who exhibit one or more "high risk" factors identified by the national Joint Committee on Infant Hearing. 9 These high risk factors include: family history of hereditary childhood hearing loss; low birth weight; infections, such as rubella, or bacterial meningitis; and others. 7 (See appendix 1 for full list of risk factors). Approximately 7 percent to 12 percent of all babies are considered at high risk for hearing loss, 9 and they are found disproportionately among infants cared for in neonatal intensive care units (NICUs).
While high risk newborns do have much higher rates of hearing impairment, they account for only about 50 percent of all newborns with hearing loss at birth. 7 A consequence of screening only high risk neonates is that approximately only one in ten newborns is screened, and only about half of all hearing impaired infants are detected at birth. As a result, in the United States, the average age of identification for infants with hearing loss is close to three years, thus delaying diagnosis beyond the age of language acquisition. 7 This contrasts sharply with other countries such as Israel and Great Britain where the average age of identification is 7 months of age. 5
Two factors seem to be rapidly changing the focus of newborn hearing screening from only high risk infants to all infants. First, advances in screening technology are resulting in quicker, less costly testing (see cost section below). Second, the federal government has mandated that all states provide intervention and educational assistance to children with disabilities from birth to six years of age. To comply with this mandate, 15 states and the District of Columbia are screening all neonates shortly after birth and before hospital discharge. 7
b) Further diagnosis and treatment
It is important that screening be followed by further diagnosis and treatment as needed. The USDHHS Healthy People 2000 report notes that once identified, auditory thresholds in those with hearing deficit "can be improved through ... amplification ...[and] communication skills can be improved with auditory and speech and language training." In addition, "other assistive listening, alerting, or caption decoder devices ...are available for improving communication competence." 5 The federal Individuals with Disabilities Education Act (IDEA), Part H, public law 102-119 (formerly PL 99-457) may assist in providing access to evaluation and early intervention services for children with hearing impairments. (1)
c) Appropriate development and oversight of screening programs
Because of technical refinements and automation, many hearing screening programs may find it possible to utilize clerical staff, volunteers, and other lower cost nonprofessionals to administer the hearing tests. However, it has been stated that screening programs should be established and maintained with the consultation and oversight of appropriately trained, skilled personnel, including audiologists. 8
5. Newborn hearing screening in Minnesota
Minnesota currently has a single hospital which is conducting universal newborn hearing screening. The program, at the greater Staples hospital in Staples, Minnesota, began in February, 1997. A brief description of the program is found in Appendix 2. Gillette Children's Hospital, in St. Paul, Minnesota, the District One Hospital in Faribault, Minnesota, and the Olmsted Community Hospital in Rochester, Minnesota, are reported to also be considering universal infant hearing screening.
Bills have been introduced in the Minnesota State Legislature in recent years requiring various forms of universal newborn hearing screening, or supporting universal screening as a goal to be achieved in the near future. As of mid-April 1997, none of these bills had yet been enacted.
Minnesota is one of 17 states participating in a newborn hearing screening program which is funded by a $1.3 million grant from the U. S. Public Health Service. The program, which is designed to screen at least 85 percent of newborns annually for hearing problems, will be coordinated through the University of Colorado-Boulder. UC-Boulder will work with program coordinators from participating states to select appropriate screening technologies for each state, and will also investigate the impacts of hearing screening on childhood development. 10
Findings
A. Effectiveness of newborn hearing screening
The predictive value of newborn hearing screening - that is, the ability to correctly distinguish between those infants who truly have hearing impairment and those who do not on the basis of the test - is a function of its specificity and sensitivity. Sensitivity is a measure of how often a test will correctly identify patients with a particular condition. Conversely, specificity is a measure of how often a test will correctly identify patients not having a particular condition. Specificity and sensitivity vary by type of hearing test. The table below shows findings on specificity and sensitivity of the two main forms of hearing tests:
Concerns have been raised that newborn hearing screening will result in a high number of "false-positives" - infants who test positive for hearing loss when in fact they have normal hearing. The presence of false-positive results necessitates rescreening of normal hearing infants. Critics of screening, particularly of EOAE, "contend that parents are unduly worried by the false-positives results generated by EOAE testing; 98% to 99% of their infants will prove to have normal hearing" after being retested. 7 Proponents of testing note that only 7 percent of newborns tested under a universal hearing screening program failed a first EOAE screen and required follow-up testing. They also point out that the 7 percent failure rate is an improvement over earlier failure rates for EOAE, and is less than the 7 percent to 12 percent of newborns initially "screened" to determine whether they are at high risk for hearing loss, and who then are subsequently referred for ABR testing. 11
A further concern is that the efficacy of EOAE and ABR testing may be affected by temporary middle ear conditions that are prevalent in newborns. 7 Additional follow-up and diagnosis may be necessary to distinguish these temporary conditions from more serious permanent problems
B. Costs of newborn hearing screening
The costs of newborn hearing screening are primarily a function of the expense of equipment, staffing, supplies, and related overhead or indirect costs. Charges for the tests vary widely by type of test, where and how the test is performed, and by whom.
The table below summarizes charges for newborn hearing screening reported from an April, 1996 survey of 119 universal newborn hearing screening programs in 25 states, the District of Columbia, and the Department of Defense. These data are presented for illustrative purposes only.
In Minnesota, one health plan company reports the following reimbursement rates for newborn hearing testing based upon a fee schedule currently in place:
Robinette and White found that the "two most influential factors contributing to the costs of universal hearing screening programs are the prevalence of congenital hearing loss and the costs to conduct the screening tests." 1 The effect of assumptions regarding prevalence are particularly significant: assuming a $50 screening cost per child, the researchers calculated that the cost per identified child with hearing loss to be $50,000 if the prevalence rate is 1/1000, but only $8,333 if the prevalence is 6/1000. 1 They also report other studies estimating the cost of identifying "a child with significant hearing loss via universal newborn hearing," ranging from $3,364 per child identified with hearing loss to $50,000. 1 As shown in Table 3 above, billing rates for screening also vary substantially, reflecting differing costs inherent in the types and methods of screening used.
Some researchers have pointed out that the cost of identifying an infant with hearing loss is generally much less than the cost of identifying infants with phenylketonuria (PKU) or other conditions which are commonly screened at birth. 11 In contrast to the prevalence rates for hearing impairment rates at birth ranging from 1 to 6 per 1000, commonly screened conditions such as hypothyroidism, PKU, or sickle cell anemia only occur in 1 per 14,000 births. 7
C. Net health outcomes and other impacts of screening for early diagnosis and intervention
The literature is often contradictory on the issue of the health and other benefits of newborn hearing screening. The National Institutes of Health found that there is general consensus that the identification of hearing loss and initiation of intervention yields a positive benefit to the hearing impaired child's net health outcome. 7 The United States Preventive Services Task Force (USPSTF) (3) however, notes there has been inadequate evaluation to determine the effects of early testing on long-term functional and quality of life outcomes, and that there are no clinical trials showing that newborns who are tested for hearing loss soon after birth have better speech and language outcomes compared to those who do not receive the early screening. 7
While it is difficult to quantify the impact of newborn hearing screening, Apuzzo and Yoshinaga-Itano found that "infants who are identified with hearing loss early have a distinct advantage over their later identified peers" and "identification and intervention begun before 2-1/2 years benefits all infants with hearing loss, regardless of hearing impairment. This benefit is especially evident for subjects who were identified by two months of age." 13
Despite the position of the USPSTF above, the Healthy People 2000 report found that "the future of a child born with a significant hearing impairment depends to a very large degree on early identification (i.e., audiological diagnosis before 12 months of age) followed by immediate and appropriate intervention. If hearing impaired children are not identified early, it is difficult, if not impossible, for many of them to acquire the fundamental language, social, and cognitive skills that provide the foundation for later schooling and success in society. When early identification and intervention occurs, hearing impaired children make dramatic progress, are more successful in school, and become more productive members of society. The earlier intervention and habilitation begins, the more dramatic the benefits." 5
D. Cost comparisons of universal newborn hearing screening and high risk screening
An important, often controversial issue is whether to screen only high risk infants or to expand testing to all newborns. Relatively few studies have compared the costs of universal newborn hearing screening with screening targeted to only high risk babies. One widely reported study by White and Maxon addressing this issue evaluated data from a universal newborn hearing screening program in Rhode Island and found universal newborn hearing screening to be more cost-effective than screening targeted only to infants considered high risk. 11
The researchers based their cost estimates for universal screening on a two stage approach recommended by the National Institutes of Health using EOAE in the first stage, followed by ABR for those who failed EOAE. (EOAE is typically less expensive than ABR, and serves to distinguish the majority of normal infants who do not have hearing loss from those who may have hearing impairments. ABR is used in the second stage to more carefully screen those who failed the first stage screening with EOAE and are suspected of having hearing loss.) The overall cost of this approach was estimated at $26.05 per infant screened. White and Maxon reported a rate of newborn hearing impairment of 5.95 per 1000 babies screened, which resulted in an estimated cost of $4609 per infant identified with hearing loss.
When estimating the costs of screening only high risk infants, the researchers assumed that all infants would first need to be assessed as high risk, and then the high risk infants would be tested for hearing loss. White and Maxon estimated the cost of assessing all neonates for high risk factors to be $10 to $15 per baby, or approximately half the cost of the full hearing screening protocol (i.e., approximately half of $26.05) described above. The researchers also assumed that high risk infants would be screened with the technique which has typically been used for high risk babies, ABR, rather than the two stage EOAE/ABR process described above. This assumption resulted in a substantially higher cost of $150 per high risk infant screened with ABR rather than the $26.05 per neonate tested with EOAE/ABR.
Based on the findings above, total screening costs were estimated to be roughly comparable between universal screening and high risk only screening (including costs of the initial assessment to determine whether the infant was high risk). However, because it was assumed that only half of all newborns with hearing loss were identified using the high risk screening protocol, the cost of identifying each infant with hearing loss in the high risk group was roughly twice that of the universal screening group. Costs ranged from $8239 to $9920 per neonate identified in the high risk group, compared with $4609 for universal screening.4,11
E. Preliminary estimates of the costs of newborn hearing screening in Minnesota
HTAC staff prepared preliminary cost estimates of both universal newborn hearing screening and high risk only screening in Minnesota based on the White and Maxon model described above. An estimate of 64,000 live births annually in Minnesota was used in the scenarios reported below. The steps used in making the cost estimates are found in Appendix 3. Screening costs were estimated for three scenarios as follows:
- Scenario 1 - universal newborn hearing screening using the two-stage EOAE/ABR method reported by White and Maxon and recommended by the National Institutes of Health. (5)
- Scenario 2 - screening of high risk infants only using the ABR method reported by White and Maxon. (6)
- Scenario 3 - same as Scenario 2, but with new assumptions that the screening technique employed would cost the same as the two-stage EOAE/ABR method reported by White and Maxon for the universal screening scenario.
Results for each scenario are provided in the table below.
F. Discussion of findings on costs and cost considerations
The scenarios above illustrate potential total costs of newborn hearing screening programs, assuming that no testing is being conducted at present. However, some undetermined level of newborn hearing screening is already taking place in Minnesota. The incremental costs of additional services or programs to increase the number of newborns being tested for hearing loss would be less than the total costs cited above. How much less the incremental costs might be than the total costs could not be estimated from the data available.
Answering questions about costs and benefits of newborn hearing screening also requires consideration of the costs of additional diagnosis and treatment resulting from the testing, compared with the overall benefits. The appropriate research to more precisely estimate these costs and benefits has largely not yet been undertaken, and a true cost-benefit analysis of newborn hearing screening was beyond the scope of this assessment.
Summary Conclusions
Bess and Paradise suggest several criteria which may be considered for a disorder to merit screening, including: the impact of the disorder; the safety, efficacy, practicability and costs of the screening; and the availability of early treatment that is more effective than later treatment. 4 The summary conclusions below address several of these key criteria as they relate to newborn hearing screening.
Summary conclusions
- Hearing loss among newborns is a significant problem for individuals and society. Early diagnosis and treatment can reduce the impact of newborn hearing loss.
- Only 50% of newborns with hearing loss will be identified when screening is limited to high risk infants (e.g., those meeting criteria of the Joint Committee on Hearing).
- The overall cost of testing all infants with hearing loss through universal newborn screening may often be comparable to, or only slightly higher, than that of screening only high risk infants.
Summary Recommendations
On the basis of the findings and conclusions above, HTAC recommends:
- The standard of care of newborns in hospitals should include screening for hearing loss.
- The two-stage screening approach recommended by the National Institutes of Health (EOAE/ABR) is preferred. However, it is important that each community implement the type of screening that best meets its needs, and that opportunities for flexibility and innovation exist.
- Newborn hearing screening programs can be administered by paraprofessionals or volunteers. The screening programs should be established and maintained with consultation and oversight of appropriately trained, skilled personnel, including audiologists. Additional diagnostic testing and/or intervention should be performed by suitably skilled, trained personnel.
- Screening is part of a continuum of care which includes diagnosis and treatment. Infants who are screened and diagnosed with hearing loss should have access to appropriate, ongoing intervention as needed.
- Universal newborn hearing testing report distribution plan:
Notices announcing publication of Universal Newborn Hearing Testing by the Health Technology Advisory Committee and the Minnesota Health Care Commission will be sent to those on the report distribution master list. In addition, the report will be sent to the following organizations and specialty societies: Academy of Dispensing Audiologists; American Speech-Language-Hearing Association; Academy of Rehabilitative Audiology; Alexander Graham Bell Association for the Deaf; American Auditory Society; American Deafness and Rehabilitation Association; American Hearing Research Foundation; National Association of the Deaf; National Center for Law and Deafness; National Foundation for Children's Hearing Education and Research; and the National Information Center on Deafness. The report will also be submitted to the special departmental work group specified under the Laws of Minnesota, 1997 Session, Chapter 203, and charged with formulating a State plan for achieving universal screening of infants for hearing loss.
Appendix I
Indicators Associated with Sensorineural and/or Conductive Hearing Loss:
For
use with neonates (birth through age 28 days) when universal screening is not
available.
- Family history of hereditary childhood sensorineural hearing loss.
- In utero infection, such as cytomegalovirus, rubella, syphilis, herpes, and toxoplasmosis.
- Craniofacial anomalies, including those with morphological abnormalities of the pinna and ear canal.
- Birth weight less than 1,500 grams (3.3 lbs.).
- Hyperbilirubinemia at a serum level requiring exchange transfusion.
- Ototoxic medications, including but not limited to the aminoglycosides, used in multiple courses or in combination with loop diuretics.
- Bacterial meningitis.
- Apgar scores of 0- 4 at 1 minute or 0-6 at 5 minutes.
- Mechanical ventilation lasting 5 days or longer.
- Stigmata or other findings associated with a syndrome known to include a sensorineural and/or conductive hearing loss.
Source: Joint Committee on Infant Hearing, 1994 Position Statement
Appendix II
Newborn Hearing Screening Program at Greater Staples Hospital, Staples, MN
Greater Staples Hospital is the first hospital in Minnesota to provide hearing screening on a routine basis as part of the baby's standard of care. Funds to purchase the OAE testing equipment came from an education grant. The program has been endorsed by Dr. Ron Campbell, Director of Maternal and Child Health Section, the Minnesota Department of Health.
The hospital started its program February 1, 1997. Program development, including an NCHAM workshop on UNHS, took about one month. Costs for equipment purchases and staff training were estimated at $14,000. The program uses OAE for screening and HI*SCREEN software. Patients are referred to area audiologists for ABR diagnostic testing. The hospital averages 300 births per year. Community reaction has been positive; parents who had babies before the program was available, have been bringing their children in for testing. The hospital charges $5.00/baby per screening test. (Telephone conversation with Juanita Weber. Director, March 12, 1997.)
Appendix III
Applying the White and Maxon Model to Illustrate Hypothetical
Newborn Hearing
Screening Programs in Minnesota
A model developed by White and Maxon was used to illustrate a range of hypothetical newborn hearing screening programs in Minnesota. The programs described in the three scenarios below are provided only to illustrate the potential impacts of applying one set of assumptions from the literature to Minnesota. Actual costs and referral rates of any newborn hearing screening program in Minnesota may be much different than the estimates resulting from the use of the model below.
White and Maxon model - overview
(adapted from: White, K. R., and Maxon, A. B. Universal screening for infant hearing impairment: simple, beneficial, and presently justified. International Journal of Pediatric Otorhinolaryngology, 32 (1995) 201-211
In the above article, White and Maxon review the experience of the Rhode Island universal newborn hearing screening program from July 1, 1993 to December 31, 1993. During this period 4,253 infants were screened. They describe referral rates and costs for use of the two stage hearing screening recommended by the National Institutes of Health (NIH) in Rhode Island.
In the first stage of testing, infants are screened using evoked otoacoustic emissions (EOAE). Infants that fail the initial phase are retested and may be referred for further testing. Infants failing both screens are referred for further diagnosis using either Auditory Brainstem Response (ABR) and behavioral audiometry (BOA) or BOA alone.
The authors found that the fail rate of the first stage testing was approximately 7%. Only 10.6 per 1000 (1.06%) of all infants screened were referred for further diagnosis. Of the 10.6/1000 infants receiving further diagnosis, 2.8 per 1000 received both ABR and BOA, and 7.8 per 1000 received BOA only.
Based on data collected by the program, the authors calculated the following costs: the initial two stage screening was $26.05 per infant; ABR was $150 per infant; and BOA was $90/infant. White and Maxon calculated an overall identification rate of newborn hearing impaired infants of 5.95 per 1000 newborns.
White and Maxon also estimated costs and referral rates for a hypothetical screening program to test only neonates identified as high risk for hearing impairment, and compared these estimates with the data based on the Rhode Island universal newborn hearing screening experience. (See description of high risk program as part of scenarios 2 and 3 below.)
Scenario 1
In scenario one, the experience of the Rhode Island universal newborn screening program cited by White and Maxon was applied to a similar hypothetical program in Minnesota.
- The number of births annually in Minnesota was assumed to be approximately 64,000. All neonates would be screened, at a cost of $26.05 each.
- 10.6 per 1000 infants were assumed to require additional diagnosis using ABR and/or BOA.
- 2.8/1000 were assumed to receive ABR and BOA at $240 each.
- 7.8/1000 were assumed to receive BOA only at $90/each.
Calculation of numbers of newborns referred:
10.6/1000 * 64,000 = 678
neonates referred for additional diagnosis.
2.8/1000 * 64,000 = 179
neonates referred for both ABR and BOA at $240/each.
7.8/1000 * 64,000 =
499 neonates referred for BOA only at $90/each.
Scenario 1 total costs:
| $1,667,200- | 64,000 infants screened using 2-stage NIH method at $26.05/each |
| $43,008- | 179 infants referred for both ABR and BOA at $240/each |
| $44,928- | 499 infants referred for BOA only at $90/each |
| $1,755,136 |
Total cost per newborn hearing impaired infant in scenario 1:
5.95
hearing impaired infants identified per 1000 births = 5.95/1000 * 64,000 = 380.
Total screening costs divided by number of hearing impaired infants identified =
$1,755,136/380
= $4,680 per hearing impaired infant
identified.
For comparison purposes, the costs per hearing impaired infant identified can
also be calculated using the "average" prevalence reported in the literature of
3/1000 live births. Three hearing impaired infants identified per 1000 births =
3/1000 * 64,000 = 192. Total screening costs divided by the number of hearing
impaired infants identified = $1,755,136/192 =
$9,141 per hearing
impaired infant identified.
Scenario 2
This scenario examines the potential cost of screening only high risk infants. White and Maxon note that the accepted protocol for screening is to identify newborns meeting one or more of the Joint Committee on Infant Hearing (JCIH) criteria for high risk, and then to screen the high risk babies for hearing loss.
White and Maxon estimate costs of $10-$15 for every newborn to determine if the infant meets the JCIH high risk criteria. Based on data from other programs, they assume that approximately 9% of all newborns will be identified as high risk, and that all high risk infants will be tested with ABR. They then estimate that 12.5% of high risk infants fail ABR and require subsequent behavioral audiometry (BOA). Applying these estimates to Minnesota results in the following:
Calculations of referrals and costs:
- 64,000 births annually * $10 each to screen for high risk = $640,000
- 9% of 64,000 births are high risk = 5760 high risk newborns
- 5760 high risk neonates receive ABR at $150/each = 5760 * $150 = $864,000
- 12.5% of high risk infants fail ABR = 720 infants
- 720 infants receive BOA at $90/ea = 720* $90/ea. = $64,800
Scenario 2 total costs:
$640,000 (screen all infants for high
risk)
$864,000 (test all infants identified as high risk with
ABR)
$64,800 (test those who fail ABR with
BOA)
$1,568,800*
* Note: if the higher estimate of the costs of determining high risk of $15/each is used, then total costs would be $1,888,800.
Cost per newborn hearing impaired infant identified (assuming only 1/2 of all hearing impaired infants will be found in the high risk group):
- .5 * (5.95 hearing impaired infants/1000 births) * 64,000 annual live births = 190 hearing impaired infants identified
- Total screening costs divided by the number of hearing impaired infants identified = $1,568,800/190 = $8239* per high risk infant identified with hearing loss.
* Note: if the higher screening cost for high risk is used, (e.g., $15 each to screen for high risk) the cost of identifying a hearing impaired newborn would increase to $9920.
For comparison purposes, the costs per hearing impaired infant identified can also be calculated using the "average" prevalence reported in the literature of 3/1000 live births.
- .5 * (3 hearing impaired infants/1000 births) * 64,000 annual live births = 96 hearing impaired infants identified
- Total screening costs divided by the number of hearing impaired infants identified = $1,568,800/96 = $16,341
* Note: if the higher screening cost for high risk is used, (e.g., $15 each to screen for high risk) the cost of identifying a hearing impaired newborn would increase to $19,675.
Scenario 3
This scenario combines elements of scenarios 1 and 2 above, and assumes that the less expensive two stage test (EOAE/ABR) could be used to screen the high risk only group rather than the more expensive ABR.
Costs of scenario 3:
- 64,000 births screened for high risk at $10/ea. = $640,000
- 5760 neonates are identified as high risk
- The 5760 high risk infants are screened using the two stage process at $26.05/infant = 5760 high risk infants * $26.05/ea. = $150,048
- 2.8/1000 of the high risk group are referred for BOA and ABR at $240 each = 2.8/1000 *5760 high risk infants * $240 = $3,870
- 7.8/1000 of the high risk group are referred for BOA only at $90/each = 7.8/1000 * 5760 high risk infants *$90 = $4,043
Total costs of scenario 3:
$640,000 (costs of screening all newborns for
high risk)
$150,048 (costs of testing all high risk using two-stage
technique of EOAE/ABR)
$3,870 (costs of follow-up of 2.8/1000 in the
high risk group using ABR and BOA)
$4,043 (costs of follow-up of
7.8/1000 in the high risk group using only BOA)
$797,961*
* Note: if the higher estimate of the costs of determining high risk of $15/each is used, then total costs would be $1,117,962.
Cost per newborn hearing impaired infant identified:
(assuming only 1/2
of all hearing impaired infants will be found in the high risk group):
.5 * (5.95/1000) * 64,000 = 190 hearing impaired infants identified
Total screening costs divided by number of hearing impaired infants identified
=
$797,962/190 = $4,191*.
* Note: if the higher total screening cost is used, the cost of identifying a
hearing impaired newborn would increase to $5,972
For comparison
purposes, the costs per hearing impaired infant identified can also be
calculated using the "average" prevalence reported in the literature of 3/1000
live births.
- .5 * (3 hearing impaired infants/1000 births) * 64,000 annual live births = 96 hearing impaired infants identified
- Total screening costs divided by the number of hearing impaired infants identified = $797,962/96 = $8,312
* Note: if the higher screening cost for high risk is used, (e.g., $15 each to screen for high risk) the cost of identifying a hearing impaired newborn would increase to $11,645.
Appendix IV
Position Statements of Major Organizations
I. 1993 National Institute of Health (NIH) Consensus Development Panel on EarlyIdentification of Hearing Impairment in Infants and Young Children
Approximately one of every 1000 infants is born deaf. (1,5-6.0 per 1000 live births. White & Behrens 1993) Many more children develop some degree of hearing impairment during later in childhood. Any degree of hearing impairment during infancy and early childhood can have devastating effects on speech and language development, affecting learning and social/emotional growth. Furthermore, reduced ability to hear at a young age adversely affects the person's vocational and economic potential.
All newborns should be screened for hearing loss prior to being discharged from the hospital.
Universal screening is superior to a hearing protocol that screens only "high-risk" newborns because the high-risk protocol identifies only 50 percent of hearing-impaired infants.
The preferred model for infant screening should be two-stage beginning with an evoked otoacoustic emissions test (EOE) and should be followed by an auditory brainstem response test (ABR) for all infants who fail the EOE test.
II. 1994 Joint Committee on Infant Hearing Position statement
The Joint Committee on Infant Hearing endorses the goal of universal detection of infants with hearing loss as early as possible. All infants with hearing loss should be identified before three months of age, and receive intervention by six months of age.
To gain access to most infants...the Committee... recommends the option of evaluating infants before discharge from the newborn nursery. For infants discharged early or delivered at an alternative birthing site, it is desirable to have their hearing assessed before three months of age.
Audiologists should supervise infant hearing assessment programs. Personnel appropriate to the infant hearing program who are trained and supervised by an audiologist may conduct some aspects of the infant hearing program.
No direct comparison between EOE and ABR test performance is yet available. Each team of health care professionals developing and instituting a hearing screening program must identify the protocol that is most suitable for their practice.
The Joint Committee member organizations are:
American
Speech-Language-Hearing Association
American Academy of
Otolaryngology
American Academy of Audiology
American Academy of
Pediatrics
Directors of Speech and Hearing Programs in State Health and
Welfare Agencies
III. 1996 U.S. Preventive Services Task Force (USPSTF)
ABR may be useful for infants with at least one high-risk factor or for neonates who fail EOE testing.
There are insufficient data to recommend universal hearing screening using EOE testing or ABR testing.
IV. Healthy People 2000 (U.S. Department of Health and Human Services/Public Health Service 1990)
If hearing impaired children are not identified early, it is difficult, if not impossible, for many of them to acquire the fundamental language, social, and cognitive skills that provide the foundation for later schooling and success in society.
When early identification and intervention occurs, hearing impaired children make dramatic progress, are more successful in school, and become more productive members of society.
Appendix V
Summary of comments received during the public comment period and the public hearing
An announcement of a 30 day public comment period on this report was published in the May 5, 1997 edition of the State Register. An announcement of an opportunity to provide public testimony on this report was published in the May 19, 1997 State Register. No comments or testimony on this report were received in response to either announcement.
Table 1. Current Techniques for Evaluating Hearing in Newborns
| TECHNIQUE | ACRONYM | DESCRIPTION OF TECHNIQUE |
|---|---|---|
|
Auditory Brainstem
Response | ABR |
Measurement of brain response to rapid clicks.
Electrodes are attached to the scalp. 25 minute test. |
|
Automated Auditory
Brainstem Response | AABR |
Same as ABR, but computerized device indicates only
pass or refer for diagnostic test. |
|
Transient Otoacoustic
Emissions | TEOAE |
Measurement of sounds produced by inner ear
following a single brief click. Probe inserted into ear. 5 minute test. |
|
Distortion Product
Otoacoustic Emissions | DPOAE |
Same as TEOAE except measurement follows two
brief tones at two different frequencies. |
Table 2. Sensitivity and Specificity of Two Main Forms of Newborn Hearing Testing 7
| Sensitivity | Specificity | |
|---|---|---|
| Auditory Brainstem Response (ABR) | 97%-100% | 86%-96% |
| Evoked Otoacoustic Emissions (EOAE) | 84% | 92% |
Table 3. Examples of charges for newborn hearing testing
| Technique | Type of test/staff | Range of Billing Charges | Average Billing Charges |
|---|---|---|---|
| Auditory Brainstem Response (ABR) | diagnostic/audiologist | $50 to $200 | Mean: $125 Median: N/A (only two values reported) |
| Automated Auditory Brainstem Response (AABR) | screening/staff or volunteer | $34 to $147 | Mean: $58.80 Median: $50.00 |
| Transient Otoacoustic Emissions (TEOAE) | screening/staff or volunteer | $25.34 to $79.00 | Mean: $41.20 Median: $40 |
| Distortion Product Otoacoustic Emissions (DPOAE) | screening/staff or volunteer | $20 to $150 | Mean: $54.47 Median: $30 |
- (2)
Average billing rate/newborn: Examples for illustrative purposes only. Figures are from a 4/1/96 National Center for Hearing Assessment and Management (NCHAM) survey of 119 Universal Newborn Hearing Screening Programs in 25 states, the District of Columbia, and the Department of Defense. Billing rates will vary depending on variables such as screening personnel used (i.e., audiologist, staff or volunteers), length of test, supplies, and administrative costs. Mean and median charges calculated by HTAC staff.]
Table 4. Reimbursement rates for newborn hearing screening tests by one Minnesota health plan company
| Technique | Reimbursement Rate | Staff |
|---|---|---|
| Evoked Otoacoustic Emissions (EOAE) | $86.50 | Performed by audiologists |
| Auditory Brainstem Response(ABR) | $158.34 | Performed by audiologists |
| Automated Auditory Brainstem Response (AABR) | $35.00 to $147.00 | Performed by trained staff or volunteers |
Table 4. Preliminary cost estimates of hypothetical newborn hearing screening in Minnesota under differing scenarios
| (HTAC staff, 1997. Modeled after White and Maxon, 1995 11 . Assumes use of 2-stage screening technique for universal screening recommended by the National Institutes of Health. See Appendix 3 for additional detail.) | |||
| Note: The preliminary cost estimates presented in Table 4 are provided for illustrative purposes only, and are likely to be highly influenced by the assumptions used. | |||
| Scenario 1 - Universal newborn hearing screening | Scenario 2 - Screening only high risk infants with ABR | Scenario 3 - Screening only high risk infants with EOAE/ABR protocol as used in Scenario 1. | |
| Total cost of screening | $1,755,136 | $1,568,800 to $1,888,800 | $797,961 |
| Total number of infants screened | 64,000 | 5,760 | 5,760 |
| Number of infants identified with hearing loss | A) 380 | A) 190 | A) 190 |
| B) 192 | B) 96 | B) 96 | |
| * Cost per hearing impaired newborn identified | A) $4,680 | A) $8,239 to $9,920 | A) $4,191 to $5,97 |
| B) $9,141 | B) $16,341 to $19,675 | B) $8,312 to $11,645 | |
Note: Two values are given. One value - (A) - is calculated based on an assumed prevalence of newborn hearing loss of 5.95/1000 (per White and Maxon). The other value - (B) - assumes an "average" rate of neonatal hearing loss of 3/1000 reported in the literature.
References and Bibliography
- 1.
- Robinette MS, White KR The state of newborn hearing screening . 1997;(Unpublished)
- 2.
- Joint Committee on Infant Hearing. 1994 position statement. 1994:38–41. [PubMed: 7818604]
- 3.
- Combs JT Office screening for hearing loss. Contemporary Pediatrics . 1995;12:132–142. [PubMed: 10158879]
- 4.
- Bess FH, Paradise JL Universal screening for infant hearing impairment: Not simple, not risk-free, not necessarily beneficial and not presently justified. Pediatrics . 1994;93:330–334. [PubMed: 7848392]
- 5.
- Healthy people 2000: National health promotion and disease prevention objectives. 1990. pp. PHS–50212. [PubMed: 2119475]
- 6.
- Meister S Emerging risk: failure to detect hearing disability in newborns. The problem: lack of screening programs for "normal newborns". QRC Advisory . 1993;10:1–4. [PubMed: 10130971]
- 7.
- Winifred S.Hayes Preliminary technology evaluation report: Neonatal hearing screening. 1996. pp. 1–29.
- 8.
- Joint Committee on Infant Hearing: 1994 Position statement. Audiology today . 1994;November/December:6–9.
- 9.
- White KR, Vohr BR, Berhens TR Universal newborn hearing screening using transient evoked otoacoustic emissions: Results of the Rhode Island Hearing Assessment Project. Seminars in hearing . 1993;14:18–29.
- 10.
- News release from Oct 2, 1996: $1.3 million infant hearing screening grant to aid infants in Colorado, 16 other states . 1996.
- 11.
- White KR, Maxon AB Universal screening for infant hearing impairment: simple, beneficial, and presently justified. Int J Pediatr Otorhinolaryngol . 1995;32:201–211. [PubMed: 7665267]
- 12.
- Universal newborn hearing screening fact sheet. 1995.
- 13.
- Apuzzo ML, Yoshinaga-Itano C Early identification of infants with significant hearing loss and the Minnesota Child Development Inventory. Seminars in hearing . 1995;16:124–139.
- Universal Newborn Hearing Screening - Minnesota Health Technology AssessmentsUniversal Newborn Hearing Screening - Minnesota Health Technology Assessments
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