Full Text PA-95-009


NIH GUIDE, Volume 23, Number 42, December 2, 1994

PA NUMBER:  PA-95-009

P.T. 34

  Prosthetic Device, Hearing 
  Treatment, Medical+ 

National Institute on Deafness and Other Communication Disorders


The National Institute on Deafness and Other Communication Disorders
(NIDCD) invites applications for the support of basic and applied
research studies on issues related to predicting and measuring the
benefit received from hearing aids.  No widely accepted measures of
hearing aid benefit are currently available, nor is there a
universally accepted definition of hearing aid benefit.  In addition,
clinical measures currently used for fitting hearing aids provide
little of value in predicting user benefit, especially over the long
term.  Clinicians and researchers agree that many more individuals
than currently use hearing aids could benefit from their use.
Rational approaches to designing and providing hearing aids to
millions of hearing-impaired individuals require clinically valid
measures for predicting and determining the benefit received from
hearing aids.


The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This PA,
Prediction and Determination of Hearing Aid Benefit, is related to
the priority area of diabetes and chronic disabling conditions.
Potential applicants may obtain a copy of "Healthy People 2000" (Full
Report:  Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary
Report:  Stock No. 017-001-00473-1) through the Superintendent of
Documents, Government Printing Office, Washington, DC 20402-9325
(telephone 202-783-3238).


Applications may be submitted by domestic and foreign, for-profit and
non-profit organizations, public and private, such as universities,
colleges, hospitals, laboratories, units of state or local
governments, and eligible agencies of the Federal government.
Foreign institutions are not eligible for First Independent Research
Support and Transition (FIRST) (R29) awards.  Applications from
minority individuals, women, and individuals with disabilities are


The support mechanisms for grants in this area will be the individual
investigator-initiated research project grant (R01) and the FIRST
(R29) award.


A variety of cosmetically acceptable hearing aids, with a wide range
of processing capabilities, is available to millions of hearing-
impaired people.  Anatomical, physiological, and psychophysical
studies have provided a better understanding of the abilities and
limitations of the normal and impaired auditory system.  Clinical
tools such as real ear acoustic measures and hearing aid prescriptive
procedures have made the fitting of hearing aids a more precise
process.  Although these advances have facilitated the provision of
high-quality hearing aids, most clinicians are uncertain to what
extent a given hearing aid will benefit a given individual,
especially over the longterm.

Lack of knowledge about what constitutes or defines benefit for a
given person contributes to this problem.  Hearing aid benefit has
been defined in many ways, including: any reported improvement in a
person's quality of life related to the use of a hearing aid; a
measurable improvement in the ability to understand speech; a
perceived improvement in the quality of sound; the number of hours of
actual hearing aid use; and a decision by a hearing aid candidate to
keep or return a hearing aid.  The two main approaches to assessing
hearing aid benefit have been self-report inventories and speech
intelligibility measures.  Although each of these approaches has
provided useful information, neither has led to widely accepted valid
evaluation endpoints for the prediction or determination of hearing
aid benefit.

Measures of definitive evaluation endpoints, or definitive outcome
measures, are those that define the actual long-term benefit received
from a hearing aid.  Surrogate evaluation endpoints are intended to
be related to or predictive of the definitive evaluation endpoint.
Measures of both definitive and surrogate evaluation endpoints are
needed.  Surrogate measures allow clinical practice and research to
continue and advance as better tests are developed and as the
relationship between outcome on tests and benefit is further
elucidated.  For example, surrogate measures are important in
clinical practice for determining candidacy for a hearing aid and for
differentiating between hearing aids with respect to expected
benefit.  A continuum of evaluation endpoints probably exists.  A set
of measures more time-intensive than a typical clinical measure, but
less so than a definitive research measure, might be used in clinical
research studies of hearing aid benefit.  Studies of evaluation
endpoints along the entire continuum are needed.

Previous studies indicate that many factors may contribute to hearing
aid benefit.  Such factors include:  individual characteristics such
as performance on psychoacoustic tests, personality traits, and
cognitive factors; aspects of the acoustic environment such as noise
and reverberation; the degree and type of hearing loss; the type of
communication tasks required of the individual hearing aid wearer;
and factors related to the performance of the hearing aid itself,
such as audibility, distortion, and signal processing.  Other
parameters, such as learning and adaptation effects associated with
hearing aid use over time, may also affect hearing aid benefit.  Not
only do the factors contributing to hearing aid benefit need to be
identified and characterized systematically, but the interaction
among these factors also needs to be explored.

This initiative encourages both basic and applied research designed
to contribute to the understanding of and to the development of
measures for the prediction and determination of hearing aid benefit.
An important factor in such studies is the ability to generalize
findings to hearing-impaired individuals with respect to degree and
type of hearing loss and to age.  Since some or all of the variables
described above may vary for different subgroups of the hearing-
impaired population, this should be taken into account in study
designs, as appropriate.  A variety of approaches to the research
problems is encouraged, and topics may include, but are not limited
to those listed below:

o  development of a clear, rational, and evidence-based
characterization of hearing aid benefit, based on valid definitive
evaluation endpoints (e.g., communication benefit, comfort, ease of
use, perceived impairment) capable of predicting and measuring
hearing aid benefit

o  determination of surrogate evaluation endpoints that relate to and
are predictive of definitive evaluation endpoints in both clinical
and research settings

o  development of valid and reliable tests to measure surrogate and
definitive evaluation endpoints in both clinical and research

o  determination of both the auditory and nonauditory factors that
contribute to hearing aid benefit, including those related to the
individual hearing aid wearer, to the acoustic environment, to the
hearing aid, and to learning or adaptation effects

o  characterization of the relationships between the auditory and
nonauditory factors that contribute to hearing aid benefit

o  development of valid and reliable tests to measure the factors
that contribute to hearing aid benefit, with a special emphasis on
measures that are predictive of long-term benefit

o  development of measures of hearing aid benefit appropriate to
children and other special populations (i.e., measures that are
maximally sensitive to sensory processes, but minimally affected by
cultural, linguistic and cognitive status)


It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990.  The new policy contains some
provisions that are substantially different from the 1990 policies.

All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.

Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.


Applications are to be submitted on the grant application form PHS
398 (rev. 9/91) and will be accepted at the standard application
deadlines as indicated in the application kit.

Application kits are available from most institutional offices of
sponsored research and may be obtained from the Office of Grants
Information, Division of Research Grants, National Institutes of
Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone
(301) 435-0714.  The title and number of the announcement must be
typed in Section 2a on the face page of the application.

Applications for the FIRST Award (R29) must include at least three
sealed letters of reference attached to the face page of the original
application.  FIRST Award (R29) applications submitted without the
required number of reference letters will be considered incomplete
and will be returned without review.

The completed original application and five legible copies must be
sent or delivered to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**


Applications will be assigned on the basis of established Public
Health Service referral guidelines.  Applications will be reviewed
for scientific and technical merit by study sections of the Division
of Research Grants, NIH, in accordance with the standard NIH peer
review procedures.  Following scientific-technical review, the
applications will receive a second-level review by the appropriate
national advisory council.

As part of the initial merit review, a process (triage) will be used
by the initial review group in which applications will be determined
to be competitive or non-competitive based on their scientific merit
relative to other applications received in response to the PA.
Applications judged to be competitive will be discussed and be
assigned a priority score.  Applications determined to be non-
competitive will be withdrawn from further consideration and the
Principal Investigator and the official signing for the applicant
organization will be notified.

Review Criteria

o  scientific, technical, or medical significance and originality of
proposed research;

o  appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;

o  qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research;

o  availability of the resources necessary to perform the research;

o  appropriateness of the proposed budget and duration in relation to
the proposed research;

o  Adequacy of plans to include both genders and minorities and their
subgroups as appropriate for the scientific goals of the research.
Plans for the recruitment and retention of subjects will also be


Applications will compete for available funds with all other
applications assigned to that Institute or Center.  The following
will be considered in making funding decisions:

o  Quality of the proposed project as determined by peer review
o  Availability of funds
o  Program priorities among research areas of the program


Written and telephone inquiries concerning this PA are encouraged;
the opportunity to clarify any issues or questions from potential
applicants is welcome.

Direct inquiries regarding scientific content to:

Lynn E. Huerta, Ph.D.
Division of Human Communication
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400-C
6120 Executive Boulevard MSC 7180
Bethesda, MD  20892-7180
Telephone:  (301) 402-3461
FAX:  (301) 402-6251

Direct inquiries regarding fiscal matters to:

Sharon Hunt
Grants Management Office
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400-B
6120 Executive Boulevard MSC 7180
Bethesda, MD  20892-7180
Telephone: (301) 402-0909


This program is described in the Catalog of Federal Domestic
Assistance No. 93.173.  Awards are made under authorization of the
Public Health Service Act, Title IV, Part A (Public Law 78-410, as
amended by Public Law 99-158, 42 USC 241 and 285) and administered
under PHS grants policies and Federal Regulations 42 CFR 52 and 45
CFR Part 74.  This program is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency

The Public Health Service strongly encourages all grant recipients to
provide a smokefree workplace and promote the nonuse of all tobacco
products.  This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.


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