[Federal Register Volume 62, Number 184 (Tuesday, September 23, 1997)]
[Notices]
[Page 49692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25163]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97M-0396]


Advanced Bionics<SUP>TM</SUP> Corp.; Premarket Approval of 
CLARION<Register> Multi-Strategy<SUP>TM</SUP> 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 Advanced Bionics<SUP>TM</SUP> Corp., 
Sylmar, CA, for premarket approval, under the Federal Food, Drug, and 
Cosmetic Act (the act), of the CLARION<Register> Multi-
Strategy<SUP>TM</SUP> 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 June 26, 1997, of the approval of the application.

DATES: Petitions for administrative review by October 23, 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., rm. 1-23, Rockville, MD 20857.

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

SUPPLEMENTARY INFORMATION: On December 29, 1996, Advanced 
Bionics<SUP>TM</SUP> Corp., Sylmar, CA 91342, submitted to CDRH an 
application for premarket approval of the CLARION<Register> Multi-
Strategy<SUP>TM</SUP> Cochlear Implant. The device is a cochlear 
implant and is intended to restore a level of auditory sensation to 
individuals with profound sensorineural deafness via electrical 
stimulation of the auditory nerve. The CLARION<Register> Multi-
Strategy<SUP>TM</SUP> Cochlear Implant is indicated for the following:

Children:
    <bullet>  Two through 17 years of age. If x-rays demonstrate 
evidence of ossification, children as young as 18 months may be 
implanted;
    <bullet>  Profound, bilateral sensorineural deafness (<gr-thn-eq>90 
dB);
    <bullet>  Undergone or be willing to undergo a hearing aid trial 
with appropriately fitted hearing aids; and
    <bullet>  Lack of benefit from appropriately fitted hearing aids. 
In younger children, lack of benefit with hearing aids is defined as a 
failure to attain basic auditory milestones such as a child's 
inconsistent response to his/her name in quiet or to environmental 
sounds (Meaningful Auditory Integration Scale). In older children, lack 
of aided benefit is defined as scoring 0 percent on open-set word 
recognition (Phonetically Balanced Kindergarten Test--Word List) 
administered with monitored live-voice (70 dB SPL). Both younger and 
older children should demonstrate only minimal ability on age 
appropriate open-set sentence measures and a plateau in auditory 
development.
    On May 21, 1997, the Ear, Nose, and Throat Devices Panel of the 
Medical Devices Advisory Committee, an FDA advisory committee, reviewed 
and recommended approval of the application. On June 26, 1997, CDRH 
approved the application by a letter to the applicant from the Deputy 
Director of Clinical and Policy Review 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 October 23, 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: August 26, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-25163 Filed 9-22-97; 8:45 am]
BILLING CODE 4160-01-F