[Federal Register Volume 61, Number 250 (Friday, December 27, 1996)]
[Notices]
[Page 68270]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32880]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96M-0490]


Advanced BionicsTM Corp.; Premarket Approval of the 
CLARION Multi-Strategy 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 application by the Advanced BionicsTM Corp., 
Sylmar, CA, for premarket approval, under the Federal Food, Drug, and 
Cosmetic Act (the act), of the CLARION Multi-Strategy 
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 March 22, 1996, of 
the approval of the application.

DATES: Petitions for administrative review by January 27, 1997.

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., 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

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

SUPPLEMENTARY INFORMATION: On June 30, 1994, the Advanced 
BionicsTM Corp., 12740 San Fernando Rd., Sylmar, CA 91342, 
submitted to CDRH an application for premarket approval of the 
CLARION Multi-Strategy Cochlear Implant. The 
CLARION Multi-Strategy Cochlear Implant is intended to 
restore a level of auditory sensation to individuals with profound 
sensorineural deafness via electrical stimulation of the auditory 
nerve. CLARION is indicated for use in postlingually deafened 
adults, 18 years of age or older, with profound, bilateral, 
sensorineural deafness (greater than or equal to 90 decibels), who are 
unable to benefit from appropriately fitted hearing aids. Lack of aided 
benefit from a hearing aid is defined as scoring 20 percent or less on 
tests of open-set sentence recognition (i.e., Central Institute of the 
Deaf (CID) Sentences). Additionally, there should be no radiographic 
contraindications to receiver placement or electrode insertion.
    On July 21, 1995, the Ear, Nose, and Throat Devices Panel of the 
Medical Devices Advisory Committee, an FDA advisory committee, reviewed 
and recommended conditional approval of the application. On March 22, 
1996, CDRH approved the 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 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 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 January 27, 1997 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 24, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 96-32880 Filed 12-26-96; 8:45 am]
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