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LETFERS

TO

THE

EDITOR

957

if the savings in social expenses could not finance the screening,

you have to ask firstly, who would refuse treatment of a patient

with a 10% chance of healing, and secondly, how do you estimate

the value of a better quality of life?

Finally, it would have been valuable if Bess and Paradise would

have put forward alternative constructive suggestions to improve

early identification and thereby diminish the uncertainty of the

statistical effect of early intervention. An example of an alternative

approach would be to compare two health authority districts as

suggested by Parving.4

THE EUROPEAN CONCERTED AcTIoN ON OTOACOUSTIC

EMissIoNs

F. Grandori

(Italy)

L.

Collet

(France)

D. Kemp (Great Britain)

G. Salomon

(Denmark)

K.

Schorn

(Germany)

A. R. D. Thornton (Great Britain)

REFERENCES

1. Eggermont, Bock. Acta Otolaryngol. 1986;(suppl 429)

2. Kuhl et al. Science. 1992;255:606-608

3. Kok et al. Audiology. 199332:213-224

4. Parving A. mntIPediat Otolaryngol. 199327:29-46

To the

Editor.-We believe that universal newborn hearing screening is

a

no-cessity. Data indicate that the High

Risk

Register currently used in

many hospitals and recommended by Bess and Paradise only

identifies about 50% of congenital hearing impairments. Causing

further consternation is the fact that the average age of

identifica-tion of hearing impairment in the United

States

remains

at 3 years

of age. We know that 1/1000 children are born deaf and about

7/1000 have bilateral hearing impairments in the mild to severe

range. Adding hearing loss with late onset, hearing loss associated

with otitis media, and hearing loss affecting one ear or the high

frequency ranges, about 14/1000 school

age children

have hearing

loss significant enough to affect their learning and academic

achievement.

We also know that the less substantial the hearing loss is, the

later the identification is likely to be. Because

these

children

do

demonstrate some hearing ability, it is difficult for parents and

other observers to behaviorally assess

true hearing

status. Yet it is

the children with hearing losses other than profound deafness

who respond best to early intervention (hearing aids, parent home

programs, auditory, language and speech therapy, special

pro-school experiences). When the hearing loss is identified early (by

3 months of age), and appropriate intervention is implemented,

these children have the opportunity to learn language and com-munication skills very much like their normal hearing peers.

The financial implications of intervention and educational

ser-vices further supports early identification. Consider the following points:

I. Intervention services can start immediately upon identification of a hearing impairment; these services are usually available within

local communities and often at no direct cost or minimal

cost to

families.

2. Language is essential to learning but it is the primary barrier to

learning for children with hearing impairments; the earlier intervention starts, the better the prognosis for language com-petence, and hence the better the opportunity for participating in regular education classes.

3. Hearing losses that are in the mild to moderate range

are usually

the last to be identified, yet respond best to intervention; these children have the potential to be educated in regular education classes with minimal support.

4. Deafchildren can be educated in regular classes with the services of an educational-interpreter if they possess ago-appropriate language skills.

5. With age-appropriate language abilities, children

who

are deaf

and

hard of hearing can be employed and be contributing members

of the community.

6. Early intervention is a bargain; medical

costs increase

with longer duration before identification; education costs increase

signifi-cantly

with

intensity of services. As

an example,

the

chart

below

compares

regular

education

and

special

education cost

for

educating

Colorado

children

with hearing

impairments

for

different

levels

of

intensity

of

services, including early inter-vention (birth through 3); these

data

clearly

illustrate

the

sub-stantial cost increase

as more

services

are

required for a child. It

should

be obvious

that

we either

pay a little bit early on

in

a

child’s life

(cost of

screening and early identification services)

or pay more

later

(more intense

educational

services

due to

the child’s delays-see Table).

TABLE. Regular Education Versus Special Education in

Terms

of Cost

Placement

Annual

Cost

Excess Cost/Yr

Regular Education* $4064.75

(No special education services)

Itinerant/Consultative $5767.55 +702.80

(Usually

up to

5 h/wk of special

education

services)

Resource $6397.55 +2332.80

(Usually up to 20 h/wk of

special education services)

Self-Contained $12 389.75 +8325.00

(More than 20

h/wk

of

special

education

services)

Preschool

$8 193.98 +2129.23

(Special

education preschool 3 h/day)

Residential

$31 139.00 +27 074.25

(Placement

at Colorado

School

for the Deaf and Blind)

Early

Home

Intervention

Programt

$2600.00

(In home

family intervention-90 min/wk)

* Non-special education student cost based on 1993 state average

per pupil

operating

revenue.

t

Home

Intervention

Program-Colorado

Department

of Health,

Handicapped

Children’s

Program

(Birth-2).

Of

note also is

that it is

not possible

to

attach a monetary value

to

everything.

The family

stress

and

frustration

that

exists

when

communication between a

child

and the parents

is impaired

can-not be easily measured.

Yet

knowing a child’s problems

and

needs as

early

as possible

minimizes

the

anxiety that affects this

rela-tionship.

In summary,

we feel that the benefits

of

screening

all infants

for

hearing impairment far exceed

the problems

identified

in the Bess

and Paradise

article.

Contrary

to the authors’ beliefs, data do exist that

support

decreased

costs

to

society

with

early

identification and intervention.

Excunv

BOARD OF THE EDUCATIONAL AUDIOLOGY

ASSOCIATION

Pegy

Von

Almen

Laurie

Allen

Tammie

Adkins

Karen

Anderson

Tricia

Blake-Rahter

Kris

English

Cheryl

DeConde

Johnson,

EdD

Weld

County

School

District

Greely,

CO

80631

To the

Editor.-Neonatal

hearing screening has

come to

the forefront of interest

within

our professional

communities

and

among the general

pub-lic, particularly

over the

last year. Identifying children

with

hear-ing loss at the earliest

age possible,

however,

has been

a

long-standing tenet of audiologists, pediatricians, otolaryngologists,

at Viet Nam:AAP Sponsored on September 1, 2020

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(2)

958

LETI’ERS

TO THE

EDITOR

and early childhood specialists, based both on knowledge of

do-velopmental processes and abundant clinical experiences. Indeed,

the identification of conditions present in early childhood that can result in long-term disabilities are critical components of current

legislative (Individuals with Disabilities Education Act [IDEA],

Part H Public Law 102-119 [formerly 99-457])’ and public health

initiatives (Healthy People 2000).2 Subsequent intervention has

been shown to positively influence outcome when such programs

are initiated in early life.3 Moreover, congenital or early-onset, sensory or neurologic disorders that result in long-term

develop.-mental disabilities are known to be more costly to society when

such deficits are first detected at older ages. Thus, the concept of

hearing screening programs designed to identify debilitating

hear-ing loss in early childhood is well founded. Both the National

Institutes of Health (NIH) Consensus Statement” and the Joint

Committee on Infant Hearing (JCIH) Position Statements

(current-ly in revision) reflect this challenge of the identification of hearing loss as early in life as possible.

Recently, in their commentary in Pediatrics entitled “Universal Screening for Infant Hearing Impairment: Not Simple, Not Risk-Free, Not Necessarily Beneficial, and Not PresentlyJustified,” Bess

and Paradise6 raised important and relevant questions regarding

the concept of mass screening for hearing loss in the neonatal

period. Their letter was motivated by the Consensus Panel

State-ment that resulted from the NIH Conference of March 1 through

3, 1993. Among other recommendations, the Panel advised that universal hearing screening of all newborns be implemented; pref-erably before hospital discharge, but no later than 3 months of age. Specifically, the Panel recommended that evoked otoacoustic emissions (EOAE) be used as the first-level screening procedure, followed by auditory brainstem response (ABR) screening of all

infants who failed the EOAE screen.

Bess and Paradise articulated numerous practical and fiscal

concerns about these recommendations. Moreover, Bess and

Par-adise argued that insufficient empirical evidence exists to support

the sweeping recommendations for universal neonatal hearing

screening and a two-stage screening protocol. They further argued that neither the instrumentation currently available, nor the

test-ing and follow-up protocols suggested met the rigorous

prereq-uisites necessary for instituting any screening initiative. Bess and Paradise specifically questioned: 1) the simplicity, efficiency, reli-ability and predictive value of the screening devices/protocols

recommended; 2) the availability, accessibility, and efficacy of

treatment options; 3) the provisions for ensuring compliance with

follow-up for infants who failed screening; 4) whether thorough

cost analyses of the recommendations had been completed a priori;

and most importantly, 5) whether neonatal hearing screening was

“risk-free” when measured in human terms (the unnecessary wor-rying of parents/caregivers in cases of false-positive outcomes).

As the three pediatric audiologists who served as members of

the Planning Committee for the NIH Consensus Development

Conference, we deem it important to address the comments of

Bess and Paradise in light of our participation in, and perceptions

of, the NIH Conference and the subsequent Consensus Statement.

The body of evidence presented by numerous respected scientists

and

clinicians over the 2-day period that led to the development of the NIH Position Statement was clear. The following facts appear, then and now, irrefutable: 1) our current models for the identifi-cation of potentially-disabling hearing loss in infancy and early childhood are inadequate. For example, the use of the High-Risk Registers for the identification of infants and young children at

risk for hearing loss followed by the direct auditory screening of

those so designated7 identifies only about 50% of young children

who have congenital or early-onset permanent hearing loss;8’ 2)

except for the neonatal period, our current health-care delivery

system provides us no other opportunity to pursue an organized,

direct screen of hearing until children enter the public school system-for most, at about 5 to 6 years of age; 3) although delayed

language and speech development are the primary indicators of a

hearing disability, most parents and primary care providers do

not suspect heating loss as a possible etiology. Most primary care

providers lack sufficient information regarding normal communi-cation development and early-onset hearing loss, neither do the

majority of providers systematically evaluate speech, language or

hearing during routine well-baby visits;’2’4 4) in the United States,

the average age when permanent hearing disabilities are

identi-fied remains at about 18 months for severe to profound bilateral

impairments and as late as 60 months for unilateral impairments

or bilateral losses of lesser degree.’ Although the prevalence of

bilateral profound hearing loss has been historically reported as

1:1000 live births,

the

target population also includes mild to moderate losses/unilateral losses. For these degrees of permanent impairment, prevalence estimates are higher (1.5 to 6 per 1000 births’5’6). Thus, our goal remains to identify these children before

school age and the onset of costly academic failure and/or the

need for special service provision; 5) instrumentation (eg, EOAE

and automated ABR) is available and currently undergoing rapid

technological improvement, thereby affording simple, relatively risk-free, and cost-effective screening device options for clinicians pursuing the initiation of neonatal hearing screening programs.

We agree

with Bess and Paradise that experience and research

with well-devised and implemented mass neonatal hearing

screening programs is needed before many important questions

can be thoroughly addressed. Some of these authors’ concerns,

such as treatment efficacy, however, will likely not be amenable to

empirical study because of ethical and moral concerns. We cannot

imagine knowingly withholding intervention from a group of

young children with hearing loss as part of a planned, prospective, case-control investigation designed to determine the age and au-diometric variables that significantly influence communicative/

developmental outcome. It would seem unlikely that an

Institu-tional Review Board or more importantly, an informed parent,

would agree to deny intervention (amplification, aural

habilita-tion, medical monitoring and parent counseling) to a young child

identified as having a permanent hearing loss. The risk-benefit

ratio for such a protocol would preclude such a circumstance. The

exact “formula” for determining which children may suffer

signif-icant, long-standing consequences will likely be determined

by the

synergistic interaction of the specific degree, configuration, type and age of onset of the hearing loss, as well as the specific set of intrinsic and extrinsic factors each individual

child

brings to this unique developmental equation.

Simply viewed, the NIH Consensus Panel had two choices:

maintain the status quo or set a vision for the future. The Panel, composed of both professionals and the lay public, opted for the latter. Further, the Consensus Panel determined from the data

presented

that

current technology would allow the direct and

accurate screening of hearing in very young children. One could

argue that the cause might have been better served if the Panel

had

been less specific about the test protocol and time

lines,

for

example, while placing more emphasis on the development of

sito-specific innovative

alternative

approaches to the early

identi-fication of hearing loss. Hindsight not withstanding, the NIH

Consensus Panel took an important, decisive and knowingly con-troversial position on newborn hearing screening.

The importance of Bess and Paradise’s critical commentary on

this important topic is appreciated. Their article has challenged professionals to re-examine positions, long-held beliefs, and cur-rent screening initiatives. We also believe, however, that such commentary should not dissuade professionals from aggressively pursuing the vision of universal early identification and

amelio-ration of hearing loss. This goal must be maintained as one of our

most important clinical challenges. To suggest otherwise would be

to deny that optimal child development is facilitated by the rich

and abundant input provided through hearing.

JUDITH

S.

GRAVEL,

PHD

Albert

Einstein

College

of Medicine

and

the

Montefiore

Medical

Center

Bronx,

NY

ALLAN

0.

DIEioi,

PHD

Indiana

University

School

of Medicine

Indianapolis, IN

NOEL

D.

MATKIN,

PHD

Children’s Hearing Clinic

University

of Arizona

Tucson,

AZ

REFERENCES

I. Early intervention programs for infants and toddlers with handicaps:

final regulations. Fed Reg. 198954:(#119)26306-26348

2. Healthy People 2000. United States Department of Health and Human Services, Public Health Service. Healthy People 2000: National Health

at Viet Nam:AAP Sponsored on September 1, 2020

www.aappublications.org/news

(3)

LETFERS

TO THE EDITOR

959

Promotion and Disease Prevention Objectives. Washington, DC: US Gov-ernment Printing Office; 1990

3. Infant Health and Development Program. Enhancing the outcomes of low-birth-weight, premature infants. A multisite, randomized trial.

JAMA. 1990;263:3035-3042

4. NIH Consensus Panel Report. Newsletter. Ambulatory Pediatr Assoc. 1993;29:18-28

5. Joint Committee on Infant Hearing. 1990 Position Statement. AAP News.

April 1991;7:6,14. Reprinted in Policy Reference Guide, 6th edition. Elk Grove Village, IL: American Academy of Pediatrics; 1993:343-346 6. Bess FH, Paradise J. Universal screening for infant heating impairment:

not simple, not risk-free, not necessarily beneficial, and not presently

justified. Pediatrics. 1994;93:330-334

7. American Speech-Language-Heating Association. Guidelines for

audio-logic screening of newborn infants who are at-risk for heating

impair-ment. ASHA. 1989;31:89-92

8. Mahoney TM, Eichwald JG. The ups and “Downs” of high-risk hearing screening: The Utah statewide program. Semin Hear. 1987;8:155-163

9. Epstein 5, Reilly JS. 5ensorineural hearing loss. Pediatr Clin North Am. 198936:1501-1520

10. Stein L, Clark 5, Kraus N. The hearing-impaired infant: patterns of identification and habilitation. Ear Hear. 1983;4:232-236

1 1. Elssmann S. Matkin N, Sabo M. Early identification of congenital

sen-sorineural hearing impairment. Hear

J.

19879:13-17

12. Shah C, Chandler D, Dale R. Delay in referral of children with impaired

hearing. Volta Rev. 1978;80:207

13. Kenworthy 01, Triggs E, Perrin J, Bess F. Current-screening practices of primary care physicians. Paper presented at the Conference on Otitis Media and Development: Screening, Referral and Treatment. 1987;

Vanderbilt University, Nashville, TN

14. Diefendorf AO, Weber BA. Identification of hearing loss: programmatic and procedural considerations. In: Roush J, Matkin N, ads. Infants and Toddlers with Hearing Loss: Family-Centered Identification, Assessment and

Intervention. Baltimore, MD: York Press; 1994:43-64

15. White KR, Behrens TR, ads. The Rhode Island Hearing Assessment Project: implications for universal newborn hearing screening. Semin

Hear. 1993;14:l-119

16. Watkin P, Baldwin M, McEnery G. Neonatal at risk screening and the

identification of deafness. Arch Dis Child. 1991;66:1130-1135

In

Reply.-We are pleased that our challenge’ of the National Institutes of

Health Consensus Conference recommendation2 that all infants be

screened for hearing impairment within the first 3 months of life,

and preferably before discharge from the newborn nursery, has

generated so much response. We thank Dr Miller for his approv-ing comments and particularly for his suggestions concerning

screening-related research. We also welcome the provocative

ro-joinders from the proposed screening program’s advocates, first,

because in answering their various criticisms we hope to shed

further light on key component issues, and second, because

heightened attention in these pages to the problem of hearing loss

in young infants can only lead to heightened general vigilance and therefore earlier case detection.

OVERVIEW OF THE ISSUES

Unarguably, all infants with handicapping degrees of hearing

impairment should ideally be identified as early as possible.

How-ever, it is important to emphasize at the outset that universal

screening within the first 3 months of life will identify relatively

few infants with hearing impairment who would not have been

identified by screening all newborns who meet high-risk-register

criteria3 and/or are admitted to an intensive-care nursery (HRR/

ICN infants). On the other hand, the added cost of universal

screening-in monetary terms and, more importantly, in harm done-could be immense.

Collectively, the respondents advocating an early infant

screen-ing program have underrated the problems it would pose in

implementation and follow-through, overstated its potential

ben-efits, and virtually ignored its indirect costs and risks.

Regarding implementation andfollow-through, the advocates have

glossed over complex issues involving in-hospital personnel ro-quirements and logistics, particularly in the face of the rapidly

growing, if not virtually universal practice of discharging

new-borns within 24 to 48 hours of birth. They have also largely failed

to address procedures for fulfilling

standard

screening-program

requirements, particularly 1) assuring in advance the availability

of

adequate resources-facilities, personnel,

and

financing-for

accomplishing recommended interventions; 2) establishing and

maintaining mechanisms for maximizing and monitoring

compli-ance; and 3) educating and counseling parents of infants with

false-positive test results and evaluating the near- and long-term impact of those results.

In projecting benefits, the advocates have, variously, 1)

broad-ened the definition of handicapping hearing loss to include

chil-dren with milder degrees of sensorineural loss (in whom

unto-ward developmental effects, and

the

effectiveness of early

intervention, are uncertain) thereby arriving at higher estimates of

prevalence than the 0.1% (1:1000) rate we used in calculating

expected outcomes of the recommended screening protocol; 2)

neglected to distinguish between cases in which hearing loss is

present at birth and therefore would be potentially detectable by

the screening program proposed, and cases in which hearing loss

develops only later and therefore would not be detectable by

screening early in infancy; 3) failed to note that relatively early

identification is already being accomplished in many locales; 4)

projected more optimistic estimates of the validity of the proposed

screening protocol than are justified

by a comprehensive

overview

of experience

to date;

5) failed to make clear the differences to be

expected

in cost-yield relationships between screening HRR/ICN infants

and

screening

healthy,

non-HRR/ICN infants; and 6)

as-sumed a greater degree of certainty about the efficacy of early

intervention for infants with hearing impairment than is justified by available evidence.

Regarding

costs and

risks, the respondents

advocating

universal

screening have failed to confront the fact that, of the hundreds of thousands of initial test failures by infants each year that would

result

from

the proposed

screening

program,

over

95% would be falso-positives by even the most optimistic estimates of test

valid-ity. Thus, few of the advocates mentioned, and none

acknowl-edged as substantial concerns, the quantum of needless parental

anxiety, potentially harmful labeling, and other psychological

dis-turbance

that the proposed

program might generate among fam-iies of normally-hearing infants. Finally, none of the advocates adverted to another, more consequential risk of universal infant screening

that

we cited

in our commentary,’ namely, the risk of unnecessary

or

harmful

diagnostic

procedures

or treatments

car-ried out on children.

INDWIDUAL ISSUES

Here we address, summarizing for brevity, the various

argu-ments

advanced

by the respondents

advocating

universal

screen-ing. Parentheses indicate by whom the respective arguments were

advanced.

Prevalence

of Hearing

Loss

Respondent argument: Ifone includes mild to moderate unilateral and bilateral sensorineuraihearing loss, the overallprevalence may be as high

as 0.6%, rather than the 0.1% rate that we used (Gravel et al; Hall;

Northern; Robinette). Including mild to moderate loss is justified by

studies showing speech and language delays secondary to the mild conductive loss that accompanies otitis media (Vohr).

Reply:

True

prevalence

is poorly

understood.

Prevalence

rates

will

vary depending

on the population

tested,

the

type

and degree

of hearing

loss, the tests used

to measure

hearing,

and the ages at

which

the hearing

tests

were

administered.

As noted

previously,

the higher

estimates

of prevalence

cited

include

cases

in which sensorineural

loss would

not yet have

developed

or been

detect-able during

early

infancy.

Regarding mild

to moderate

hearing

loss,

studies

attributing

speech

and language

delays to mild conductive loss secondary to

otitis media

have

had

major

limitations

and cannot

be

considered

conclusive.46

For

that reason, and because

the

developmental

effects

of milder

degrees

of sensorineural

loss also are

uncertain, it seems inappropriate at present to include infants with such loss in

the target

population

of any screening

program.

Regarding moderate to profound unilateral and bilateral

sen-sorineural

loss-for

which

we agree screening would be

justified

if

the screening

protocol

gave

satisfactory

outcomes-prevalence

in

the ICN

is around 2 to 4%,7

whereas

estimates

of prevalence

in

the well-baby

nursery

range

from 0.05 to

0.l%,”

ie, about

#{188}o

the

prevalence

in the ICN.

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1994;94;957

Pediatrics

Judith S. Gravel, Allan O. Diefendorf and Noel D. Matkin

Letter to the Editor

Services

Updated Information &

http://pediatrics.aappublications.org/content/94/6/957.2

including high resolution figures, can be found at:

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entirety can be found online at:

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Reprints

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Information about ordering reprints can be found online:

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1994;94;957

Pediatrics

Judith S. Gravel, Allan O. Diefendorf and Noel D. Matkin

Letter to the Editor

http://pediatrics.aappublications.org/content/94/6/957.2

the World Wide Web at:

The online version of this article, along with updated information and services, is located on

American Academy of Pediatrics. All rights reserved. Print ISSN: 1073-0397.

American Academy of Pediatrics, 345 Park Avenue, Itasca, Illinois, 60143. Copyright © 1994 by the

been published continuously since 1948. Pediatrics is owned, published, and trademarked by the

Pediatrics is the official journal of the American Academy of Pediatrics. A monthly publication, it has

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