Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA Implantable Middle Ear Draft Guidance Follows Panel Recommendations

This article was originally published in The Gray Sheet

Executive Summary

Direct comparisons of conventional hearing aids to implantable middle ear hearing devices should be performed when preparing a premarket approval application, according to an FDA 1draft guidance

You may also be interested in...



Implantable Middle Ear Hearing Device Control Comparison Weighed By CDRH

FDA will need to decide whether a planned guidance on implantable middle ear hearing devices should allow sponsors to control against unaided conditions

FDA In Brief

August ENT panel meeting: FDA's Ear Nose and Throat Devices Panel will meet Aug. 16 in Gaithersburg, Maryland to discuss and make recommendations on the recently issued implantable middle ear hearing device draft guidance (1"The Gray Sheet" June 17, 2002, p. 11). Topics to be addressed include "appropriate study population, objective measurement techniques for comparison of acoustic hearing aids and middle ear hearing devices and subjective questionnaire development for determining postoperative effectiveness and quality of life outcomes," according to the 2ENT meeting announcement. Requests for formal oral presentations should be submitted to FDA by Aug. 8...

FDA In Brief

August ENT panel meeting: FDA's Ear Nose and Throat Devices Panel will meet Aug. 16 in Gaithersburg, Maryland to discuss and make recommendations on the recently issued implantable middle ear hearing device draft guidance (1"The Gray Sheet" June 17, 2002, p. 11). Topics to be addressed include "appropriate study population, objective measurement techniques for comparison of acoustic hearing aids and middle ear hearing devices and subjective questionnaire development for determining postoperative effectiveness and quality of life outcomes," according to the 2ENT meeting announcement. Requests for formal oral presentations should be submitted to FDA by Aug. 8...

UsernamePublicRestriction

Register

LL026487

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel