[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]
BILLING CODE 4160-01-F
