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DOES OAE/A-ABR HEARING SCREENING MISS HEARING LOSS?
2005 EDHI Conference
Jean L. Johnson, DrPHJean L. Johnson, DrPHCenter for Disability StudiesCenter for Disability Studies
Director (Interim)Director (Interim)
March 3, 2005March 3, 2005
Atlanta, GA
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International Conference on Newborn Hearing Screening, Diagnosis and Intervention
Cernobbio, Italy - May 2004
Second Annual Conference of the CDC Centers on Birth Defects and Developmental Disabilities
Washington, DC – July 2004
Asia Region Neonatal Screening ConferenceShanghai, China - September 2004
UH College of Education Research SymposiumHonolulu, HI - October 2004
American Speech-Language and Hearing AssociationPhiladelphia, PA – November 2004
CDC Ad Hoc Group – TeleconferenceJanuary 11, 2005
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Research Team
Principal Investigator - Jean Johnson, DrPH Research Coordinator - Karl R. White, PhD
Diagnostic Evaluation Coordinator - Judith E. Widen, PhD
Site Co-Principal Investigators
Judith Gravel, PhDMichele James, AuD
Teresa Kennalley, MAAntonia B. Maxon, PhD
Lynn Spivak, PhDMaureen Sullivan-Mahoney, MA
Betty Vohr, MDYusnita Weirather, MA
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Funded by the Centers for Disease Control and Prevention
CDC Consultants:June Holstrum, PhDRoy Ing, MD, MPHBrandt Culpepper, PhDKrista Biernath, MD Lee Ann Ramsey, BBA, GCPH
under a Cooperative Agreement with:The Association of Teachers
of Preventive Medicine
with a sub-agreement to:The University of Hawai`i
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Why is early identification of hearing loss so important?
• Hearing loss occurs more frequently than any other birth defect.
• Undetected hearing loss has serious negative consequences.
• Dramatic benefits are associated with early identification of hearing loss.
It is true for severe to profound loss.Is it also true for milder hearing loss?
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Background National Institutes of Health (NIH) Consensus Panel
recommended in March 1993 that:
“the preferred model for screening should begin with an evoked otoacoustic emissions test and should be followed by an auditory brainstem response test for all infants who fail the evoked otoacoustic emissions test.”
Continuing improvement of ABR technology led to a number of hospitals in the US implementing a variation of the NIH recommendation that was based on automated ABR (AABR)
Anecdotal reports to the Centers for Disease Control and Prevention (CDC) in the mid to late 1990’s that the two-stage OAE/AABR protocol was not identifying some infants with permanent hearing loss.
The CDC issued a competitive Request for Proposals in 2000 to investigate whether the OAE/AABR screening protocol was not identifying babies with hearing loss.
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Oto-Acoustic Emissions (OAE) Screening
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Auditory Brain Stem (ABR)Screening
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AABRScreening
Comprehensive HearingEvaluation Before 3 Months
of AgeFail Fail
Pass Pass
Discharge Discharge
OAE Screening Prior toHospital Discharge
Research Question
Are infants with permanent hearing loss not being identified when newborn hearing screening is done with a two-stage OAE/A-ABR protocol in which infants who fail OAE and pass AABR are not followed?
Study SampleComprehensive Audiological Assessment at 8-12 months of age
Comparison Group
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Criteria for Selecting Sites• 2,000 or more births per year
• Established newborn hearing screening program with at least six month history of success
• Historical refer rates of less than 10% for OAE and 4% for ABR
• Success in obtaining follow-up on 85% or more of referrals
• Ethnic and socio-economic distribution similar to US population
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Participating Sites
Name of Hospital Location
Arnold Palmer Hospital Orlando, Florida
Good Samaritan Hospital Columbus, Ohio Jacobi Medical Center New York, New York
Kapi`olani Medical Center Honolulu, Hawaii
Long Island Jewish Medical System New York, New York
Via Christi Regional Medical Center Kansas City, Kansas
Women & Infants Hospital Providence, Rhode Island
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Enrollment Process• Eligible babies (Failed OAE and Passed A-ABR) were
identified following newborn hearing screening.
• Parents were contacted and research study explained.
• Consent was obtained from families.
• Enrollment data was collected.
• Contact was maintained with family at 2, 4, & 6 months of age via post cards.
• Babies were seen for audiological diagnostic evaluation at 8-12 months of adjusted age.
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Date Collected for Each Participating Baby
Birthdate Bronchio-pulmonary Dsplasia
Gender Mechanical Ventilation >7 Days
Birth Weight ECMO
Gestational Age Number of Children in Home
APGAR Scores Number of Adults in Home
Days in NICU Total Household Income
Malformations of the Head and Neck Child’s Race/Ethnicity
Syndrome Associated with Hearing Loss Health Insurance
In-utero Infections Family History of Hearing Loss
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Study Sample
1,524 Infants Enrolled
973 (63.8%) Returned for Evaluation
1,432 Ears Evaluated
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Enrollment of Study Participants
Enrollment Period
Births During
Enrollment
Referral
OAE
Rate
ABR
Recruitment From
Site #1 May 1, 2001 to Dec 31, 2002
16,608 6.3% 0.8% WB/NICU
Site #2 June 1, 2001 to Jan 31, 2003
9,393 4.5% 0.9% WB/NICU
Site #3 May 1, 2001 to Jan 31, 2003
24,032 2.4% 0.8% WB/NICU
Site #4 Sep 20, 2001 to Jan, 2003
4,509 8.0% 1.0% WB
Site #5 May 15, 2001 to Jan 31, 2003
9,252 3.1% 0.8% WB
Site #6 May 1, 2001 to Jan 31, 2003
16,623 5.3% 1.2% WB/NICU
Site #7 May 1, 2001 to Jan 31, 2003
6,217 9.6% 2.8% WB/NICU
Total 86,634 4.8% 1.0%
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Number of Babies:
Births During
EnrollmentEligible for Enrollment
Total Enrolled Number Not Recruited
Number of Refusals
Site # 116,608 1,044 191 418 435
6.3% 18.3% 40.0% 41.7%
Site # 29,393 421 370 18 33
4.5% 87.9% 4.3% 7.8%
Site # 324,032 456 170 11 275
1.9% 37.3% 2.4% 60.3%
Site # 44,509 285 84 186 15
6.3% 29.5% 65.3% 5.3%
Site # 59,252 209 147 30 32
2.3% 70.3% 14.4% 15.3%
Site # 6 6,217 433 266 50 117
7.0% 61.4% 11.5% 27.0%
Site # 716,623 614 296 71 247
3.7% 48.2% 11.6% 40.2%
Total 86,634 3,462 1,524 784 1,154
4.0% 44.0% 22.6% 33.3%
Enrollment of Study Participants (continued)
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Audiological Diagnostic Evaluation
• Visual reinforcement
audiometry (VRA)
• Tympanometry
• OAE - Either TOAE or DPOAE
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VRA Protocol
• Protocol patterned after National institutes of Health Study (Norton, Univ. of Washington)
• Responses at 500, 1K, 2K, 4K Hz
– Order of testing 2K, .5K, 4K, 1K
– Aiming for minimal response level of 15 dB HL
• Multiple visits often necessary to complete testing
– 68% completed in 1 visit
– 24% required 2 visits
– 8% required 3 or more visits
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Category Criteria
Not Permanent Hearing Loss
Using the ”best” results from all assessments, MRL thresholds of < 20dB at 1K, 2K, and 4K.
Probable Not Permanent Hearing Loss
Complete MRL data not available at 1K, 2K, and 4K, BUT* All frequencies had MRLs < 20dB OR OAEs within normal limits* OR Tone burst ABR data < 25dB.
Permanent Hearing Loss (PHL)Sensorineural
MRLs > 25dB at 1K, 2K, or 4K (tested with good confidence) OR ABR threshold > 30dB; AND if tested, OAEs below normal limits at the frequencies with elevated MRLs; AND normal middle ear functioning based on tympanometry or bone conduction.
Permanent Hearing Loss (PHL) Conductive
MRLs > 25dB at 1K, 2K, or 4K (tested with good confidence); AND if tested, OAEs below normal limits; AND bone conduction thresholds < 20dB with an Air/Bone gap > 15dB at frequencies with MRLs > 25dB.
Increased Suspicion of PHLHigh Suspicion
MRLs > 25dB at 1K, 2K, or 4K, BUT OAEs within normal limits for those frequencies OR only fair confidence in VRA testing.
Some Suspicion * MRLs > 30dB at 1 frequency or > 25dB at more than one frequency, BUT abnormal tympanometry AND no bone conduction.
* Sound field thresholds > 25dB (with fair confidence) AND normal tympanometry AND OAEs below normal limits.
Not Sufficient Data to Rule Out PHL
* No MRLs or OAEs within normal limits for 1K, 2K, or 4K and none of the above criteria for permanent hearing loss are met.
* OAEs within normal limits were defined as > 3-6dB at 1K and > 6dB at 2K and 4K.
Criteria for Categorizing Hearing Loss
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# of Infants with Dx Data
Percent of Infants
w/ Dx Data
Total Ears
Not PHL Permanent Loss
Hearing
(PHL)
Increased
of
Suspicion
PHL:
Probable Not PHL
Not Sufficient
Data
SNHL PC High Some
Site #1
81 42.4% 148 131 0 0 0 0 6 11
Site #2
299 80.8% 478 432 7 0 0 0 35 4
Site #3
42 50.0% 59 40 0 0 0 2 6 11
Site #4
109 74.1% 165 82 10 5 17 12 24 15
Site #5
86 50.6% 111 58 2 0 0 5 16 30
Site #6
184 69.2% 241 202 4 0 2 8 8 17
Site #7
172 58.1% 230 195 2 0 0 1 5 27
Total 973 63.8% 1432100%
114079.6%
25
1.7%
5
0.3%
19
1.3%
28
2.0%
100
7.0%
115
8.0%
Hearing Status of Study Ears from All Hospitals
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SN PC Total SN PC Total
16,608 17 1 18 24 2 26 1.08 1.2% 82.4%
199 164
9,393 18 1 19 31 2 33 2.02 1.5% 95.7%
140 134
4,509 4 0 4 6 0 6 0.89 0.2% 88.9%
9 8
9,252 16 0 16 27 0 27 1.73 0.3% 96.4%
28 27
24,032 39 3 42 60 3 63 1.75 0.8% 87.6%
193 169
6,217 16 1 17 25 2 27 2.73 0.7% 65.9%
41 27
16,623 36 6 42 55 6 61 2.53 0.6% 79.8%
94 75
86,634 146 12 158 228 15 243 1.82 0.8% 85.8%704 604
Site # 5
Site # 7
Site # 6
Total
Site # 1
Site # 2
Site # 3
Site # 4
All Comparison Group Sites
Births during
enrollment
Babies w/ PHL Ears w/ PHLReferred for Dx Completed Dx
Prevalence of PHL (per
1000)
PHL in Comparison Group Sites(Fail OAE/Fail A-ABR)
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PHL in Ears of Study Infants that Passed Initial OAE
Ears of Study Infants that Passed Initial OAETotal Ears Not PHL Permanent
Loss
Hearing
(PHL)
Increased
of
Suspicion
PHL:
Probable Not PHL
Not Sufficient
Data
SNHL PC High Some
Site #1 13 11 0 0 0 0 0 2
Site #2 112 107 0 0 1 0 3 1
Site #3 25 3 0 0 1 0 15 6
Site #4 53 19 0 0 2 6 15 11
Site #5 53 30 0 0 1 2 5 15
Site #6 127 60 0 0 3 1 38 25
Site #7 113 30 0 0 0 0 22 61
Total 496
100%
260
52.4%
0
0.0%
0
0.0%
8
1.6%
9
1.8%
98
19.8%
121
24.4%
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Mild
(25-40 dB)
Moderate
(41-70 dB)
Severe through
Profound
(>70 dB)
Total Infants
Study Group 15
71.4%
5
23.8%
1
4.8%
21
100.0%
Comparison Group
31
19.6%
64
40.5%
63
39.6%
158
100.0%
Total 46
25.7%
69
38.5%
64
35./%
179
100.0%
Degree of Hearing Loss in Study and Comparison Group Babies
80.3%
28.6%
As measured in the worse ear
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Comparability of Study and Comparison Groups
What Percent of “Referred” Babies Did Sites Try to
Follow?
What Percent of “Followed” Babies Were Diagnosed?
Study Group
(Fail OAE/ Pass A-ABR)44% 64%
Comparison Group
(Fail OAE/ Fail A-ABR)100% 87%
Reasonable to adjust prevalence rates for those who were not recruited
Adjusting prevalence rates for differences in the percent of diagnostics completed is problematic
Families who think their child has a hearing loss are more likely to return
Families that are poor, single heads of household, transient , etc are less likely to return and these variables may be correlated with the incidence of hearing loss
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How Many Additional Babies with Permanent Hearing Loss (PHL) were Identified?
Comparison Group(Fail OAE/ Fail A-ABR)
Study Group(Fail OAE/ Pass A-ABR)
Total
Number of Babies 158 21 179Prevalence per 1,000 1.82 .24 2.06
*Adjusted for proportion of OAE fails that enrolled
Represents 12% of all babies with PHL in birth cohort
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Is it important that 21 Babies (30 ears) with PHL were found?
• How many does it add to what would have been identified otherwise?
• How many ears with hearing loss were found among those that passed the initial screen?
• How many babies would you have to follow to find 21 babies PHL?
• Is this congenital or late-onset hearing loss?
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How many babies must be screened to find 21 with PHL?
The obvious answer is 973, but….• This ignores that most screening programs
that use OAE also do second stage OAE screen (usually following hospital discharge)
• Such outpatient screening is less expensive than the diagnostic protocol used in this study
• Difficulty of getting babies to return for outpatient screening must be considered
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Screening Failures
PassedScreening
FailedScreening
False Positives
True Positives
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Cost of Screening
• Direct cost
• Indirect cost
• Follow-up cost
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Cost-Benefit of Screening
Benefit COST Good follow-up
Benefit COST Mediocre follow-up
Benefit COST Poor follow-up
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Were any of these ears late-onset losses?
• This study was not designed to answer that question.
• We do know that IF all of the ears with risk factors had been followed and identified, 9 of 21 babies would still have been missed
• Little is known about the incidence or what predicts late-onset hearing loss
• Most (>3/4ths) of the hearing losses “missed” were mild as was expected
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Different Criteria for Determining Permanent Hearing Loss
Comparison Group
Study Group
Total
Based only on those meeting criteria for PHL
1.82 .24(21 babies)
2.06
Including those categorized as high suspicion of PHL
1.82 .43(33 babies)
2.49
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Different Criteria for Determining Permanent Hearing Loss
Comparison Group
Study Group
Total
Based only on those meeting criteria for PHL
1.82 .24(21 babies)
2.06
Including those categorized as high suspicion of PHL
1.82 .43(33 babies)
2.49X XX X
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Variation Among Sites
The study design assumed that sites are all equally well implemented
To the degree that this isn’t true, data from some sites may be a better estimate of the number of babies being missed
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# of Study Group
Infants with PHL
Average “Rank” for Implementation Quality
of Site
Births During
Enrollment Period
% and N of Eligible Infants
Enrolled
% and N of Refusals During
Recruitment
% Returning
for Diagnostic Evaluations
% with “Not Sufficient
Data”
Site # 1 0 5.8 16,608 18.3%191
41.7%435
42.4% 7.4%
Site # 2 5 1.3 9,393 87.9%370
7.8%33
80.8% 0.8%
Site # 3 0 4.8 4,509 29.5%84
5.3%15
50.0% 18.6%
Site # 4 10 2.8 9,252 70.3%147
15.3%32
74.1% 9.1%
Site # 5 2 6.0 24,032 37.3%170
60.3%275
50.6% 27.0%
Site # 6 3 3.0 6,217 61.4%266
27.0%117
69.2% 7.1%
Site # 7 2 4.5 16,623 48.2%296
40.2%247
58.1% 11.7%
Indicators of Implementation Quality at Each Site
PHL=permanent hearing loss
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Presumed Curve of Health Care
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Bell-Shaped Curve of Health Care
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Best Estimate of Amount of PHL Missed by OAE/AABR protocol
12% of children with PHL in birth cohort
23% of children with PHL in birth cohort
Babies Who Failed OAE / Failed AABR
Babies who failed OAE/ Passed AABR
Based on 44% that participated
Adjusted for those who did not participate
All Sites 1.82 2.06(.24 increase)
2.37(.55 increase)
Sites with Best Implementation
2.27 2.75(.48 Increase)
2.95(.68 increase)
23% of children with PHL in birth cohort
17% of children with PHL in birth cohort
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What’s the Best Estimate of the Number of Babies Missed by the OAE/AABR
Screening Protocol?
• Depends on the criteria used for determining PHL
• Variation among sites
• Adjustments for Differences Between Study and Comparison Groups
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Conclusions
The OAE/AABR protocol, as implemented at these sites, failed to identify a substantial number of infants with PHL.
Best estimate is .55 per thousand or 24% of all infants with PHL.
Most were mild sensorineural hearing loss
Impossible from this study to determine how many are late-onset losses
About 41% might be identified if all infants with risk factors or opposite refer ears were followed, but this is not likely.
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Screening for permanent hearing loss should extend into early childhood (e.g. physician’s offices, early childhood programs).
Emphasize to families and physicians that passing hospital-based hearing screening does not eliminate the need to vigilantly monitor language development.
Screening program administrators should ensure that the stimulus levels of equipment used are consistent with the degree of hearing loss they want to identify.
The relative advantages and disadvantages of the two-stage (OAE/A-ABR) protocol need to be carefully considered for individual programs.
Recommendations
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Prevalence and methods of identifying late-onset hearing loss
Identification and monitoring of progressive hearing loss
Ongoing investigation of sensitivity of various screening protocols and equipment (including what level of hearing loss is targeted)
Practicality and cost-efficiency of alternative or additional “continuous” screening and surveillance techniques, especially in early childhood
Further Research Recommendations
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Questions to Ponder
• What degree of hearing loss do you want to identify?
• What cost will be required for that identification?
• Can you assure that follow-up will occur?• What interventions can you provide?• How can you provide continuing surveillance
of late onset or progressive loss?• How comfortable are you with the quality of
services being provided?
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Key Large-Scale Newborn Hearing Screening Studies in the United StatesLocation/Dates Cohort Size Nurseries Screening
Techniques Refer Rates
Follow Up Rate Prevalence Per 1000 of Hearing
Loss
RIHAP 3
(8/90 – 2/91)
1,850 NICU & WBN OAE / ABR
26.9% 73%
5.95
Colorado
(1/92-12/96
27,938 NICU & WBN AABR 2.56
Rhode Island
(1/93 – 12/95)
53,121 NICU & WBN OAE / ABR
14.7%
74--88%a 2.00
New Jersey
(1/93 – 12/95)
15,749 NICU & WBN ABR
3%
3.3 overall
2.00 – WBN
13.0 NICU
Hawai‘i
(1/94 – 12/95)
9,605 WBN OAE 89% 4.15
Texas
(1/94 – 6/97)
54,228 NICU & WBN OAE & AABR
3.5%
82.3% 3.14
NIDCD
(1994-1997)
4,478
2,701
NICU & WBN ABR-
TOAE-
DPOAE-
64.4%
(Research)
56.0
New York
(1/96 – 12/96)
69,761 NICU & WBN OAE & AABR 72% 8.00 (NICU)
0.9 (WBN)
Washington, DC
(2/97 – 12/02)
39,437 NICU & WBR TOAE
1.6%
82.7 2.3 overall
1.9 WBN
6.8 - NICU
ATPM/CDC
(5/2001 – 1/2003)
86,634 NICU & WBN OAE: 4.8
AABR: 1.0
63.8(Research)
85.8
2.05
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Other Dissemination
• Article has been selected for publication in Pediatrics
• Five articles prepared for publication in American Journal of Audiology
• Presentation at Council on Exceptional Children Conference in Baltimore in April 2005.
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Additional Information on Newborn Hearing Screening
www.infanthearing.org
www.babyhearing.org
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Deafness separates people from people.--- Helen Keller