[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 BionicsTM Corp.; Premarket Approval of
CLARION Multi-StrategyTM 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 BionicsTM Corp.,
Sylmar, CA, for premarket approval, under the Federal Food, Drug, and
Cosmetic Act (the act), of the CLARION Multi-
StrategyTM 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
BionicsTM Corp., Sylmar, CA 91342, submitted to CDRH an
application for premarket approval of the CLARION Multi-
StrategyTM 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 Multi-
StrategyTM Cochlear Implant is indicated for the following:
Children:
Two through 17 years of age. If x-rays demonstrate
evidence of ossification, children as young as 18 months may be
implanted;
Profound, bilateral sensorineural deafness (90
dB);
Undergone or be willing to undergo a hearing aid trial
with appropriately fitted hearing aids; and
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
