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QUESTIONS SUBMITTED BY THE SUBCOMMITTEE Senator HARKIN. Thank you very much. There will be some additional questions which will be submitted for your response in the record.

[The following questions were not asked at the hearing, but were submitted to the Institute for response subsequent to the hearing:)

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QUESTIONS SUBMITTED BY THE SUBCOMMITTEE

STATE-OF-THE-ART RESEARCH

Question. We've talked in the past about the need to bring the science that supports deafness and communication disorders up to par with the science that supports and investigates other categories of disease. One of the major problems in this field has been the lack of trained molecular biologists and other scientists with state-ofthe-art specialties. I was pleased to see that we were able to increase the number of individuals trained by your Institute from 112 to 149 between 1990 and 1991. Unfortunately, your 1992 request would only maintain the 149 trainees. In your professional judgment, how many training slots should be supported in 1992 to help bring the science of deafness and communication disorders up to par with other fields of science?

Answer: In my professional judgment 208 training slots should be supported in 1992.

TRAINING

Question. If the Congress were able to provide funding to your Institute above the 1992 requested level, what relative priority would you assign to providing more funding for training?

Answer. Training is of critical importance. It is the foundation upon which excellence in research is built. Training and career development remain a high priority for the NIDCD. We are very pleased that the National Multipurpose Research and Training Centers are offering continuing education and research training to physicians.

Question. Dr. Snow, I understand that you made a proposal to NIH management that would provide a supplement to research project grants to permit additional training to take place in the context of work being done on research project grants. This would be a new mechanism, a new way of attempting to train more individuals. What is the status of this proposal at NI and how much do you estimate it would cost to add this training component to your research project grants in FY 1992?

Answer. We have received tentative approval from the NIH for our "Mentor" program and are now working on the final details of the proposal. I believe this program can offer our investigators an excellent opportunity to move into the forefront of biomedical research by learning research techniques in molecular biology, thereby giving them the tools needed to provide us with answers in such difficult areas as hereditary deafness and the regeneration of hair cells. We estimate that this initiative would cost $4,350,000 in FY 1992 and could be accommodated within our overall request if deemed a priority. In FY 1992 the second year costs of the FY 1991 awards would be supported; and approximately twice as many new awards would be made as in FY 1991.

Question. How much would it cost to add this component to your research project grants in FY 1991 and is this something that the Director's Discretionary Fund can be used for?

Answer. The "Mentor" program would cost approximately $1,350,000 in FY 1991. We anticipate making awards in the third or fourth quarter of FY 1991. We will propose it to the NIH as a possible use of the NIH Directors' Discretionary Fund.

RESEARCH PLAN

Question, In January of 1989, the Institute developed a research agenda to cover all seven areas of the Institute; smell, taste, hearing, balance, language, voice and speech. This year, I understand, you have an effort underway to update the National Strategic Research Plan for language and balance and that with recurring updates the entire plan will be updated every 3 years. Why did you choose language and balance to begin your update and what areas will be updated in FY 1992?

Answer. The National Deafness and Other Communication Disorders Advisory Board unanimously agreed to update two of the six research sections of the National Strategic Research Plan each year. The National Advisory Board selected the Balance and Vestibular Systems and the Language Sections for updating in 1990-1991, the Hearing and the Voice Sections in 1991-1992, and the Smell and Taste and the Speech Sections in 1992-1993.

BRAIN IMPLANTS SIMILAR TO COCHLEAR IMPLANTS

Question. Dr. Snow, we have talked about cochlear implants and we have a very excellent program at the University of Iowa that is continuing research on cochlear implant development. I understand that there is research underway to actually implant something in the brain to stimulate areas of the brain that are related to hearing, if the nerve cells are dead within the ear. Are animal experiments underway with regard to such brain implants?

Answer. Research is indeed under way to determine the optimum design, effectiveness and potential side effects of an auditory: brainstem implant (ABI). This electric prosthesis, similar to the more familiar cochlear implant, is positioned in the lateral recess of the 4th ventricle of the lower brainstem, abutting the dorsal cochlear nucleus.

Question. treatments?

Could you update us on the prospects for such

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Answer. Its use is indicated in cases where the auditory nerve has been damaged by the presence of tumors, as in neurofibromatosis type 2 (NF 2) or severed by skull fracture following head injury-situations in which a cochlear implant could be useless. Animal studies have been conducted to determine the optimum electrode design and location, safety of long-term electric stimulation to brain structures, and effectiveness in producing awareness of sound.

Question. human beings?

Do you believe they are feasible in the long run for

Answer. More recently, a prototype device has been implanted in 19 patients with bilateral hearing impairment due to NF 2. Their ability to understand speech with the ABI is, on the average,

comparable to speech understanding performance achieved with multichannel cochlear implants. At least one manufacturer intends to refine the device and begin marketing, pending completion of these studies and FDA approval.

CLEARINGHOUSE

Question, I understand that you awarded the contract for your National Clearinghouse last month and it will come on line next month. Could you update the Committee on the National Clearinghouse operations?

Answer. The National Institute on Deafness and Other Communication Disorders Clearinghouse began start-up operations on March 1, 1991. The scope of the Clearinghouse is a direct reflection of the mandate that established it. The objectives of the Clearinghouse include: provision of effective responses to information requests; coordination of the vast amount of information that already exists in the field of communication sciences and distribution of it to health professionals, patients, industry, and the public; and, establishment of a central resource center that will provide access to current information held by other sources to avoid duplication. The Clearinghouse will maintain databases, develop informational materials including fact sheets, brochures and reprints and will continue, in close cooperation with the Institute staff, to disseminate information in the communication sciences.

INFANT ASSESSMENT

Question. Dr. Snow, your strategic research plan describes an urgent research goal relating to the early identification of hearing disorders in young children, ideally by the age of 9 months. While there are several methods for identifying hearing impairment during the first several months of life, the average age of identification of these problems is two and a half years. What additionally needs to be done to meet this goal of neonatal identification of hearing disorders and what additional research needs to be done in this area?

Answer. At the present time, most authorities would recommend the use of a hospital-based high-risk registry and the use of auditory brainstem response testing of those infants found to be at risk. Unfortunately, 50 percent of the infants with hearing impairment are missed by this approach. One method currently under investigation is otoacoustic emissions testing. Otoacoustic emissions are sounds generated by the normal ear. They are low in intensity, but can be detected in the ear canal using a sensitive microphone and modern methods of signal analysis to extract these low level signals from ambient background noise. The time, equipment and personnel required make it much less expensive than other methods of testing and much more suitable for screening of all infants. Therefore, otoacoustic emissions testing may prove to be an inexpensive, practical method of early detection of hearing loss in infants and may help to reach the goal of reducing the average age of diagnosis from 2.5 years to the first several months of life. The NIDCD is planning a clinical trial to assess the efficacy of this method of testing in the near future.

Question. Also, I understand there are 14 states that have legislative mandates to perform neonatal hearing screening. Will additional state legislation be required in this area to achieve the goal?

An'swer. The fact that a state has a législative mandate does not mean that actual screenings are taking place. Program implementation varies widely for each state, ranging from fully implemented programs to only the release of brochures on the subject. Most of the legislation makes no mention of specific funding policies to be followed. The method of testing may or may not be recommended or regulated by the state. Testing processes vary from state to state and may include only one method or several methods. To achieve our goal of early identification of hearing impaired children, a uniform nationwide effort must be undertaken.

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Sixteen states now have legislative mandates to perform neonatal hearing screening. These are Hawaii, Kansas, Arizona, California, Connecticut, Florida, Georgia, Kentucky, Maryland, Massachusetts, Mississippi, New Jersey, Ohio, Oklahoma, Rhode Island and Virginia.

MULTI-PURPOSE RESEARCH AND TRAINING CENTERS

Question. There are three of the Multi-purpose Research Training Centers funded and in operation and competition is underway for two more this fiscal year. When will the awards for these new Centers be made?

Answer. The Request for Applications for the new National Multi-purpose Research and Training Centers (RTC) was issued in the NIH Guide to Grants and Contracts on December 22, 1990. As of February 21, 1991, the Institute has received six applications in response to the RFA. The awards for these new Centers will be made by September 1991.

Question. What will the focus area be for each of these new Centers?

Answer. The program focus for these Centers will be determined by the relative scientific merit of the competitive applications approved for funding by the National Deafness and Other Communication Disorders Advisory Council.

RESEARCH CENTERS

Question. Your budget shows a request for one additional center in 1992. What type of center do you propose for funding in 1992 and will this bring on line all the centers called for by the legislation establishing the Deafness Institute?

Answer. The NIDCD is hoping to initiate a Core grants program in 1992. Core Grants for the support of Research in the Communication Sciences and Disorders are intended to support the provision of central services and/or resources that enhance or facilitate the studies of a group of investigators currently holding investigator-initiated NIDCD grant support. Core grants may indirectly serve a number of purposes: for example, the establishment and support of appropriate laboratory services may

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