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

Loud And Clear Need In US For OTC Hearing Aids For Mild To Moderate Loss, Congress Tells FDA

Executive Summary

Hearing loss is one of the most common conditions affecting older US consumers, with nearly one in three between the ages of 65 and 74 having difficulty hearing, Sens. Warren and Grassley and Resp. Kennedy and Carter note in urging FDA to finalize regulations allowing certain hearing aids to be sold OTC.

You may also be interested in...



Biden Joins House And Senate Asking For FDA's Attention On Making Hearing Aids Available OTC

One of 72 items in an executive order by the president on promoting competition in the economy notes that 14% of the around 48m US consumers with hearing loss use hearing aids because, on average, they cost more than $5,000 per pair, costs often not covered by health insurance.

MDUFA IV (And More) Is Law: Trump Signs A Health-Care Bill

President Trump's eleventh-hour signature on the FDA Reauthorization Act puts into play about $1bn in device user-fee collections from industry through FY 2022, new US FDA performance goals and a range of device process enhancements and reforms supported by industry.

House To Link Inspections, 3rd-Party Servicer, OTC Hearing Aid Bills To User-Fee Train

A House Health subcommittee wants to attach a quartet of medtech bills to a fast-moving user fee package in Congress. The bills, which got a hearing before the Energy and Commerce Committee Health Subcommittee May 2, would streamline inspections and third-party certifications of device exports, refine FDA regulations on over-the-counter hearing aids, make third-party device equipment servicers register and file complaints with the agency, and clarify FDA product-center jurisdiction for contract agency-dependent imaging equipment.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS150709

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