HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Making Hearing Aids, Or Are They PSAPs? US FDA Offers Revised Draft Guidance To Help

Executive Summary

Revised draft guidance document explains difference between hearing aids, regulated as medical devices, and personal sound amplification products, which aren’t. Guidance published with draft to allow hearing aids to be sold OTC.

You may also be interested in...



US Proposed OTC Hearing Aid Rule Inspired Soundly Founder To ‘Make This Process Easier’

In recent interview, CEO Blake Cadwell talked about Soundly’s business model and outlook for hearing aid marketplace after FDA's pending publication of rule aiming to make the devices more accessible. Firm since June has offered online testing and advice for customers about hearing aids best suited for their needs.

Facilitating More OTC Switches In US Graduates To Regulatory Plan On FDA’s Unified Agenda

For first time rules for novel switches and OTC hearings aids are parts of “significant regulatory actions” in agency’s plans. Information is added in Unified Agenda items explaining likely benefits and costs from the changes.

Speaking Of Medtech, Ep. 10: FDA’s TAP Pilot

In this FINAL EPISODE of Speaking Of Medtech: The US FDA got something it desperately wanted in its latest user-fee package with industry: a Total Product Lifecycle Advisory Program pilot, or TAP. The agency says TAP will allow for earlier and more frequent engagement with developers – but is it needed?

Topics

Latest News
See All
UsernamePublicRestriction

Register

RS151865

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