INTERVENTION STRATEGIES FOLLOWING IDENTIFICATION OF NEONATAL HEARING
IMPAIRMENT

Release Date:  October 30, 1998

PA NUMBER:  PAS-99-011

P.T.

National Institute on Deafness and Other Communication Disorders

Letter of Intent Receipt Dates:  Jan 15, 1999, May 14, 1999, Sep 15, 1999
Application Receipt Dates:  Feb 18, 1999, Jun 18, 1999, Oct 18, 1999

PURPOSE

The National Institute on Deafness and Other Communication Disorders (NIDCD)
invites research grant applications that address intervention strategies
following identification of neonatal hearing impairment.  Areas of interest
include, but are not limited to: hardware (e.g., hearing aids, cochlear
implants and other sensory aids); behavioral treatment programs; development
of outcome measures to determine the benefit of intervention strategies; and,
studies on the efficacy of intervention.  Up to five awards may be made under
this solicitation subject to the scientific quality of the applications
received and the availability of funds.

HEALTHY PEOPLE 2000

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 Program Announcement (PA),
Intervention Strategies Following Identification of Neonatal Hearing
Impairment, is related to one or more of the priority areas.  Potential
applicants may obtain a copy of "Healthy People 2000" at
http://www.crisny.org/health/us/health7.html.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, for-profit and non-
profit organizations, public and private, such as universities, colleges,
hospitals, laboratories, and units of State or local governments, and eligible
agencies of the Federal government.  Racial/ethnic minority individuals,
women, and persons with disabilities are encouraged to apply as Principal
Investigators. 

MECHANISM OF SUPPORT

This PA will use the NIH research project (R01) mechanism.  Responsibility for
the planning, direction, and execution of the proposed project will be solely
that of the applicant. The total project period for an application submitted
in response to this PA may not exceed five years.  The earliest date of award
is January 1, 2000.

This PA is a one-time solicitation with three specified receipt dates in 1999. 
Future unsolicited competing continuation applications will compete with all
investigator-initiated applications and will be reviewed according to the
customary NIH peer review procedures.

FUNDS AVAILABLE

Research grant applications submitted in response to this PA will compete for
approximately $1 million in direct costs that will be made available for the
first year of support.  It is anticipated that up to five awards will be made.
The number of awards will depend on the overall scientific merit of the
applications and the availability of funds in Fiscal Year 2000.

RESEARCH OBJECTIVES

Background

The early identification of children with hearing impairment is an important
public health objective, with as many as 33 children per day born with
significant hearing impairment in the United States.  The consequences of a
late diagnosis of hearing impairment are delays in spoken language and
literacy.  Without appropriate and timely intervention, early childhood
hearing impairment interferes with the development of oral/aural
communication, impedes academic performance, and results in harmful long-term
vocational consequences.

In 1993, an NIH Consensus Development Conference on Early Identification of
Hearing Impairment in Infants and Young Children recommended universal
screening of all infants for hearing impairment.  This recommendation set the
stage for the tremendous growth in universal newborn hearing screening
programs over the last five years.  Many states now screen all live births and
others are introducing and passing legislation in support of this endeavor. 
In the near future approximately 19 states will screen all newborns for
hearing impairment before discharge from the hospital, and this number will
likely increase rapidly in the next decade.

It has long been recognized that a necessary sequel to the identification of
hearing loss in an infant or child is the implementation of intervention
strategies that, to the extent possible, mitigate the effects of the
disability.  There is clear evidence that infants begin speech and language
acquisition early in the neonatal period, and furthermore, that perturbations
in that normal process produce lasting deficits.  While an exact "critical
period" for the effects of hearing loss on speech and language development is
unknown, the first six months of life are critically important.  As neonatal
hearing screening is implemented throughout the United States, new and
improved intervention strategies are needed.

In March of 1998, the NIDCD convened a Working Group on Early Identification
of Hearing Impairment to provide advice on the most pressing research
questions regarding diagnostic and intervention strategies following neonatal
hearing screening, taking into account the age of identification and the
degrees of hearing impairment that are being identified in neonatal hearing
screening programs.  Current studies indicate that approximately 10-20 percent
of the infants identified through neonatal hearing screening have profound
hearing impairment.  Thus, the majority of the identified infants have lesser
degrees of hearing impairment, for which treatment outcomes are virtually
nonexistent.

Intervention strategies for neonatal hearing impairment typically have not
begun until the child is at least six months of age and often not until the
child is 2 years or older.  These strategies typically involve the fitting of
some form of hardware (e.g., hearing aids, cochlear implants, vibrotactile
devices, FM auditory and other assistive devices, or some combination of these
devices) and a behavioral treatment program [e.g., a home or clinic-based
program to facilitate speech, language (manual and/or aural/oral) and auditory
skill development].  Hearing aids are the most commonly employed assistive
device for most levels of sensorineural hearing impairment and are, in most
instances, fitted only after the hearing impairment is well-characterized. 
For profound hearing impairment, cochlear implants are becoming more commonly
used as the age limits for implantation are lowered; vibrotactile and other
assistive devices are less commonly used but remain an important option in the
intervention process.  Currently, the rationale for the selection and fitting
of these sensory aids on infants and young children remains elusive since
there is little information based on research to guide clinicians on the
fitting of hardware in neonates and young children.

In addition to fitting hardware (e.g., hearing aids, cochlear implants or
other assistive devices), behavioral treatment programs are often initiated to
mitigate the effects of hearing impairment on the communicative, educational,
and social development of the child.  These programs are varied, with some
emphasizing a combination of signed and spoken language, while others focus on
the development of oral and auditory communication only.  Clearly, the degree
of hearing impairment, as well as many other factors, impacts the decision of
what type behavioral treatment program a given child is enrolled in.  There
have been few well-controlled studies of the efficacy of such treatment
programs, and these focused predominantly on individuals who are either deaf
or have profound hearing impairment and who were usually identified after the
neonatal period.  Since the majority of children identified through neonatal
hearing screening programs have lesser degrees of hearing impairment, there is
a critical need for information to guide clinicians in answering the questions
of when and how to intervene in this population.

Scope

The focus of this PA is on intervention strategies for infants and very young
children who have been identified as having a hearing impairment. 
Applications are encouraged that address relevant issues including, but not
limited to: hardware (hearing aids, cochlear implants and other sensory aids);
behavioral treatment programs; development of outcome measures to determine
the benefit of intervention strategies; and, studies on the efficacy of
intervention.  The majority of children with hearing impairment identified by
neonatal hearing screening have degrees of hearing impairment less than
profound.  Thus, research programs should take into account both the age of
identification and the degree of hearing impairment identified in neonatal
hearing screening programs, thereby optimizing the management of the entire
spectrum of infants with hearing impairment.

Applications that address one or more of the following research topics are
encouraged:

o  Selection and fitting of hearing aids and cochlear implants for infants and
young children (e.g., comparison of available prescriptive methods and
strategies, development of new methods and strategies).

o  The comparative benefits of other, less frequently used hardware, such as
assistive listening devices and vibrotactile devices, used alone or in
conjunction with hearing aids or cochlear implants.

o  Development of outcome measures for determining the benefit of various
device fitting strategies in infants and young children, allowing for the
effects of age and maturation, the type of technology and signal processing
strategy in use, and the type, degree, configuration, and etiology of hearing
impairment.

o  Consideration of practical issues relating to hearing aid and cochlear
implant utilization, such as ergonomics and changes in auditory structures
occurring with maturation (e.g., rapid growth of the pinna in infants affects
the proper fit of earmolds, often resulting in acoustic feedback).

o  Development of intervention models based on a "best fit" between the
intervention and a constellation of subject and environmental factors, such as
degree of hearing impairment, age at diagnosis and intervention, family
environment, socioeconomic status, intervention type (e.g., center-based/home-
based; family-centered/child-centered), culture, skill and accessibility of
the provider.

o  Studies identifying and characterizing the components of effective
intervention strategies and determining the commonalties among successful
programs.

o  Development of appropriate outcome measures to determine the efficacy of
intervention programs for infants with hearing impairment.  Issues to be
addressed include family and parent-child interactions, baseline measures
(benchmarks of development that constitute "appropriate" development), as well
as age-specific and function-specific measures.

o  Studies of the efficacy of intervention strategies, including child- and
family-focused outcomes.

o  Long-term effects of intervention strategies and devices (e.g., hearing
aids, cochlear implants, assistive listening systems, tactile devices,
combinations of these), including issues related to plasticity and short-and
long-term sensory deprivation. 

It is expected that all applications in response to this PA will propose
research involving human subjects.  Rapid integration of new techniques and
laboratory-research findings into clinical or habilitative/rehabilitative
programs remains a high priority for all research needs as outlined in this
document.  Translational research will facilitate the rapid and efficient
integration of research findings into clinical practice.  Thus, priority will
be given to applications with a translational component or that are clinically
applicable by design.

SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

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 protocols 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 policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 10.1-43).

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 in the NIH Guide for Grants and Contracts, Volume 23,
Number 11, March 18, 1994, available on the web at the following URL address: 
http://www.nih.gov/grants/guide/notice-files/not94-105.html.

NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN
RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them. 
This policy applies to all initial (Type 1) applications submitted for receipt
dates after October 1, 1998.

All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: http://www.nih.gov/grants/guide/notice-files/not98-024.html.

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

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes a
descriptive title of the proposed research, address, and telephone number of
the Principal Investigator, names of other key personnel and, if applicable,
participating institutions, and the number and title of the PA.  There are
three dates for submitting applications in response to this solicitation. 
Each date is preceded by a due date for submitting a letter of intent, January
15, 1999, May 14, 1999, and September 15, 1999, respectively.  Although a
letter of intent is not required, is not binding, and does not enter into the
review of subsequent applications, the information that it contains allows
NIDCD staff to estimate the potential review workload and to avoid possible
conflict of interest in the review.

The letter of intent is to be sent to:

Chief, Scientific Review Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, EPS 400C
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-8693

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
5/95). Application kits are available at most institutional offices of
sponsored research and may be obtained from the Division of Extramural
Outreach and Information Resources, National Institutes of Health, 6701
Rockledge Drive, MSC 7910, Bethesda MD 20892-7910, telephone 301/710-0267, E-
mail: GrantsInfo@nih.gov, and from the program administrator listed under
INQUIRIES. 

Applicants planning to submit an application requesting $500,000 or more in
direct costs for any year must contact the Institute program staff before
submitting the application (i.e., as plans for the study are being developed). 
Furthermore, the applicant must obtain agreement from the program staff listed
under INQUIRIES that the NIDCD will accept the application for consideration
for award.  Finally, the applicant must identify, in a cover letter sent with
the application, the staff member and Institute or Center who agreed to accept
assignment of the application.  Refer to the NIH Guide for Grants and
Contracts, March 20, 1998, at http://www.nih.gov/grants/guide/notice-
files/not98-030.html.

The number and title of the PA ("Intervention Strategies Following
Identification of Neonatal Hearing Impairment") must be typed on line 2 of the
face page of the application form and the YES box must be marked.

Submit a signed, typewritten original of the application, including the
Checklist, and three signed photocopies in one package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA MD 20892-7710
BETHESDA MD 20817 (for express/courier service)

At the time of submission, two additional copies of the application must be
sent to:

Chief, Scientific Review Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, EPS 400C
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-8693

The Center for Scientific Review (CSR) will not accept any application in
response to this PA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application.  The
CSR will not accept any application that is essentially the same as one
already reviewed.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by CSR and
responsiveness by NIDCD staff. Incomplete applications will be returned to the
applicant without further consideration.  Those judged non-responsive will be
referred back to the CSR for review in an appropriate CSR Study Section. 
Applications that are complete and responsive to the PA will be evaluated for
scientific and technical merit by the NIDCD Scientific Review Branch in
accordance with the review criteria stated below.

As part of the initial merit review, all applications will receive a written
critique and undergo a process in which only those applications deemed to have
the highest scientific merit, generally the top half of applications under
review, will be discussed, assigned a priority score, and receive a second
level review by the National Deafness and Other Communication Disorders
Advisory Council. 

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.  In
the written review, comments on the following aspects of the application will
be made in order to judge the likelihood that the proposed research will have
a substantial impact on the pursuit of these goals.  Each of these criteria
will be addressed and considered in the assignment of the overall score,
weighing them as appropriate for each application.  Note that the application
does not need to be strong in all categories to be judged likely to have major
scientific impact and thus deserve a high priority score.  For example, an
investigator may propose to carry out important work that by its nature is not
innovative but is essential to move a field forward.

(1) Significance: Does this study address an important problem? If the aims of
the application are achieved, how will scientific knowledge be advanced? What
will be the effect of these studies on the concepts or methods that drive this
field?

(2) Approach: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?

(3) Innovation: Does the project employ novel concepts, approaches or methods?
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?

(4) Investigator: Is the investigator appropriately trained and well suited to
carry out this work? Is the work proposed appropriate to the experience level
of the Principal Investigator and other researchers (if any)?

(5) Environment: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional support?

In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:

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

o  The reasonableness of the proposed budget and duration in relation to the
proposed research.

o  The adequacy of the proposed protection for humans, animals or the
environment, to the extent they may be adversely affected by the project
proposed in the application.

AWARD CRITERIA

The following will be considered in making funding decisions: quality of the
proposed project as determined by peer review, availability of funds, and
programmatic priorities as determined by the National Deafness and Other
Communication Disorders Advisory Council.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or questions
from potential applicants is welcome.  Inquiries regarding programmatic and
scientific issues may be directed to:

Amy M. Donahue, Ph.D.
Division of Human Communication
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, EPS 400C
Bethesda, MD 20892
Telephone: (301) 402-3458 
FAX: (301) 402-6251 
Email: Amy_Donahue@nih.gov
 
Direct inquiries regarding fiscal matters to:

Ms. Sherry Dennison
Grants Management Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, EPS 400C
Bethesda, MD 20892
Telephone: (301) 402-0909
Fax: (301) 402-1758
E-mail: Sherry_Dennison@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.173. Awards are made under the authority 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 review.

The PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and promote the non-use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.

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