[Federal Register Volume 61, Number 209 (Monday, October 28, 1996)]
[Notices]
[Pages 55644-55645]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-27613]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96M-0381]


Cochlear Corp.; Premarket Approval of New Indication for Use for 
the Nucleus 22-Channel Cochlear Implant.

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its 
approval of the supplemental application by Cochlear Corp., Englewood, 
CO for premarket approval, under the Federal Food, Drug, and Cosmetic 
Act (the act), of a new indication for use for the Nucleus 22-Channel 
Cochlear Implant. After reviewing the recommendation of the Ear, Nose, 
and Throat Devices Panel, FDA's Center for Devices and Radiological 
Health (CDRH) notified the applicant, by letter of August 21, 1995, of 
the approval of the application.

DATES: Petitions for administrative review by November 27, 1996.

ADDRESSES: Written requests for copies of the summary of safety and 
effectiveness data and petitions for administrative review to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Marilyn N. Flack, Center for Devices 
and Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2080.

SUPPLEMENTARY INFORMATION: On August 8, 1992, Cochlear Corp., 
Englewood, CO 80112, submitted to CDRH a supplemental application for 
premarket approval of an expanded indication for use for the Nucleus 
22-Channel Cochlear Implant. The device was originally approved in 1985 
for use in adults who demonstrated postlinguistic, bilateral, 
sensorineural hearing loss, and obtained little or no benefit from 
conventional amplification. It was approved in 1990 for use in children 
who demonstrated bilateral, profound, sensorineural hearing loss, and 
obtained little or no benefit from conventional amplification or 
vibrotactile hearing aids. The expanded indication for use now includes 
patients, 18 years and older, who have bilateral, postlinguistic,

[[Page 55645]]

sensorineural hearing impairment, and obtain limited benefit from 
appropriate binaural hearing aids. Limited benefit from amplification 
is defined by test scores of 30 percent or below in the best-aided 
(i.e., testing on left ear, right ear, and binaurally to determine 
communication ability obtained in that particular hearing-aided 
condition) listening condition on tape recorded tests of open set 
sentence recognition. These patients typically have low frequency 
residual hearing in the moderate to profound range and profound 
(greater than equal to 90 dBHL (decibels in hearing level)) hearing 
loss in the mid to high speech frequencies.
    On April 20, 1995, the Ear, Nose, and Throat Devices Panel of the 
Medical Devices Advisory Committee, an FDA advisory committee, reviewed 
and recommended approval of the supplemental application. On August 21, 
1995, CDRH approved the supplemental application by a letter to the 
applicant from the Director of the Office of Device Evaluation, CDRH.
    A summary of the safety and effectiveness data on which CDRH based 
its approval is on file in the Dockets Management Branch (address 
above) and is available from that office upon written request. Requests 
should be identified with the name of the device and the docket number 
found in brackets in the heading of this document.

Opportunity for Administrative Review

    Section 515(d)(3) of the act (21 U.S.C. 360e(d)(3)) authorizes any 
interested person to petition, under section 515(g) of the act, for 
administrative review of CDRH's decision to approve this application. A 
petitioner may request either a formal hearing under part 12 (21 CFR 
part 12) of FDA's administrative practices and procedures regulations 
or a review of the application and CDRH's action by an independent 
advisory committee of experts. A petition is to be in the form of a 
petition for reconsideration under Sec. 10.33(b) (21 CFR 10.33(b)). A 
petitioner shall identify the form of review requested (hearing or 
independent advisory committee) and shall submit with the petition 
supporting data and information showing that there is a genuine and 
substantial issue of material fact for resolution through 
administrative review. After reviewing the petition, FDA will decide 
whether to grant or deny the petition and will publish a notice of its 
decision in the Federal Register. If FDA grants the petition, the 
notice will state the issue to be reviewed, the form of the review to 
be used, the persons who may participate in the review, the time and 
place where the review will occur, and other details.
    Petitioners may, at any time on or before November 27, 1996 file 
with the Dockets Management Branch (address above) two copies of each 
petition and supporting data and information, identified with the name 
of the device and the docket number found in brackets in the heading of 
this document. Received petitions may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.
    This notice is issued under the Federal Food, Drug, and Cosmetic 
Act (secs. 515(d), 520(h), (21 U.S.C. 360e(d), 360j(h))) and under 
authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10) 
and redelegated to the Director, Center for Devices and Radiological 
Health (21 CFR 5.53).

    Dated: October 4, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 96-27613 Filed 10-25-96; 8:45 am]
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