Harmony Hearing Center

OTC (Over the Counter) 

Hearing Aid Act Bundled with MDUFA; Expected to Pass through Committee

Published on May 11, 2017



The Over the Counter [OTC] Hearing Aid Act of 2017 (S 670) is expected to be passed today by the Senate Health, Education, Labor & Pensions (HELP) Committee as part of the larger Medical Device User Fee Amendments (MDUFA) package which pertains to how medical device companies will pay fees to the US Food and Drug Administration (FDA) when registering their devices with the Agency.

Introduced in March by Senators Elizabeth Warren (D-Mass) and Chuck Grassley (R-Iowa), OTC Hearing Aid Act is bipartisan legislation designed to make hearing aids for those with mild-to-moderate hearing loss available over the counter. A companion bill (HR 1652) led by Representatives Joe Kennedy III (D-Mass) and Marsha Blackburn (R-Tenn) has also been introduced in the House. The bill largely mirrors legislation (S9) introduced by Senators Warren and Grassley in late 2016, and would require the FDA to propose a rule that would establish an OTC hearing aid category for adults with “perceived” mild-to-moderate hearing loss within 3 years of passage of the legislation, and finalize a rule within 180 days after the close of the comment period.

The proposed legislation would also require the FDA to write regulations ensuring that this new category of OTC hearing aids meets standards for safety, consumer labeling, and manufacturing protections, providing consumers the safe option of an FDA-regulated device at lower cost. The Act would also supersede other state laws restricting OTC device distribution, and provide for a study of the devices relative to consumer satisfaction after 3 years.

One of the most controversial aspects of the bill has been the language pertaining to OTC devices being used for “mild-to-moderate” hearing losses—or conceivably a hearing loss up to 70 dB, which many believe would not avail itself to a “do-it-yourself” healthcare approach. The American Speech Language Hearing Association (ASHA), Hearing Industries Association (HIA), and other organizations have maintained that self-directed treatment and OTC hearing aids should be recommended only for people with mild hearing loss, for whom the risks of failed intervention are outweighed by the potential benefits.

“Hearing loss is a medical issue that requires patient care and service from a hearing professional to ensure the best outcomes,” noted HIA Chairman Brandon Sawalich of Starkey Hearing Technologies. “HIA and the other hearing health organizations that have expressed concern about the OTC hearing aid bill will continue to work with members of Congress to ensure that patient safety is the top priority.”

Come back and visit often, we will publish the latest in new hearing aid technology. We will share the latest research on hearing loss, and the different manufacturers latest hearing aids.

Quality Care with Patience & Kindness

Apple Responds to the Concerns of People With Hearing Loss About New iPhone
Nov 2 2016

In the weeks following Apple’s announcement that new iPhones will not have a headset jack, HLAA received more than one call from people outraged by the company’s decision. Apple did not consider the impact removing the jack would have on people with hearing loss who use and depend on a neckloop or other wired solution to hear audio on the phone. When we brought this issue to Apple they responded.

Apparently, the “lightning jack” that has been the iPhone’s connection for recharging the battery will now double as a connector to a headset or, yes, a neckloop. Apple provides an adapter and the people in charge of accessibility at Apple tell us it’s been tested with neckloops and that it works.

While initially skeptical, we have learned from at least one independent source that the lightning connector does work with the adapter and a neckloop. But we know that not all neckloops are the same, so if you have one that doesn’t work with the Apple adapter please let Lise Hamlin know.

While we are on the subject of cell phones, let us know if it is difficult to find information about accessibility and hearing aid compatibility ratings on the websites for cell phone manufacturers such as Apple, Samsung and Motorola and carriers like Verizon, AT&T, Sprint and T-Mobile. We have found that the ratings in particular are sometimes hard to come by.

Remember, if you want to purchase any phone and the accessories that go with them, try the phone – and the accessories – before you purchase them.