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Joint Meeting of the Dental Products and Ear, Nose and Throat Devices Panels - October 6, 2004

BRANCH UPDATE

EAR, NOSE AND THROAT DEVICES BRANCH (ENTB)

Presented by:

CAPT. Eric A. Mann, M.D., Ph. D. – Branch Chief

Dr. Mann updated the panel on FDA approvals that have taken place since the last panel meeting on August 16, 2002.

An original premarket approval application (PMA) was approved on December 12, 2002 for the Karl Storz Autofluorescence System (PMA P020008) for use in white light and autofluorescence bronchoscopy to identify and locate abnormal bronchial tissue for biopsy and histological evaluation.

Supplements to previously approved PMAs also have been approved. Two supplements to the Cochlear Americas Nucleus 24 Contour Softip Electrode PMA were for (a) a longer specialized electrode tip ( 11/22/02), and (b) an “advance off stylet” insertion tool ( 10/06/03). Two supplements for the MED-EL Corporation Combi 40+ Cochlear Implants system were (a) a Medium Active Electrode Array ( 8/27/03) and (b) a MRI indication ( 6/05/03. Advanced Bionics Corporation’s supplement for the HiResolution Bionic Ear System (HIRES 90K) was approved on 7/07/03. Dr. Mann informed the panel of the subsequent Advanced Bionics recall of 9/24/04 of all unimplanted CLARION and HiResolution Bionic Ear Systems.

An announcement was made of the new CDRH Cochlear Implant Website at:

http://www.fda.gov/cdrh/cochlear that will be activated within the coming week.

PANEL DELIBERATIONS

Consideration of dental oral appliances and ear, nose and throat (ENT) devices for over the counter (OTC) use for snoring and/or obstructive sleep apnea (OSA).

After a presentation on the OTC regulation by Heather S. Rosecrans, Director of the Premarket Approval (510k) Staff, Dr. Eric Mann, gave a presentation on the nasal dilators, cervical pillows and mandibular support devices which have been clear by FDA for OTC use for snoring and/or mild OSA by the ENT Branch. Dr. Kevin Mulry then gave a presentation on tongue retaining, mandibular repositioning, and palatal lifting devices that have been cleared for prescription use only by the Dental Devices Branch.

The following chart summarizes the status of those devices with respect to the indications under discussion.

During the panel’s discussion, no vote was taken nor consensus requested of the panel. The purpose of the deliberations was to assist the Agency in formulating an approach to evaluation of future devices applications intended for OTC availability.

The panel was asked to address the issues of risk/benefit of OTC availability for above noted devices for snoring and mild, moderate, and severe OSA respectively. They were also asked to comment on elements of labeling in each category that might be used to assist the user in self-diagnosing and differentiating the severity of OSA to insure proper use and also to give labeling restrictions to prevent misuse and harm.

The panel agreed that clinical data should be included in a marketing application to assist in evaluating the safety and effectiveness of treatment. There were differing opinions on the necessity and type of controls but concurrence on the need for safety and effectiveness data, particularly for devices indicated for OSA.

Overall, the panel did not support OTC availability for any of the device types currently marketed with the prescription use only restriction.

Contact: Sara M. Thornton, Executive Secretary

(301) 594-2053, ext.127; e-mail smt@cdrh.fda.gov

TRANSCRIPTS MAY BE PURCHASED FROM: (Written Request Only)

Neal R. Gross and Co., Inc.
1323 Rhode Island Avenue, NW
Washington , DC 20005-3701
(202) 234-4433 (voice) (202) 387-7330 (fax)

or

Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane , HFI-35
Rockville , MD 20852
(301) 827-6500 (voice) (301) 443-1726 (fax)

EXECUTIVE SUMMARY MAY BE PURCHASED FROM: (Written Request Only)

Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane , HFI-35
Rockville , MD 20852
(301) 827-6500 (voice) (301) 443-1726 (fax)

Updated October 8, 2004

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