[Federal Register Volume 60, Number 243 (Tuesday, December 19, 1995)]
[Notices]
[Pages 65348-65349]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-30815]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95M-0398]


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 section 515 of the Federal Food, 
Drug, and Cosmetic Act (the act), of a new indication for use for the 
Nucleus 22-Channel Cochlear Implant. 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 January 18, 1996.

ADDRESSES: Address 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 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, 
sensorineural hearing impairment and obtain limited benefit from 
appropriate binaural hearing aids. Limited benefit from amplification 
is defined by test scores of 30 percent correct or less in the best-
aided 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 or 
equal to 90 dBHL) hearing loss in the mid-to-high speech frequencies.
    -On April 20, 1995, the Ear, Nose and Throat Devices Advisory 
Panel, an FDA advisory panel, 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 (21 
U.S.C. 360e(g)), for administrative review of CDRH's decision to 
approve this supplemental 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 supplemental 
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 

[[Page 65349]]
place where the review will occur, and other details.
    -Petitioners may, at any time on or before January 18, 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: December 4, 1995.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 95-30815 Filed 12-18-95; 8:45 am]
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