As AudiologyNOW Concludes, FDA Hearing Aid Panel Convenes

fda hearing aid meeting
Brian Taylor
April 18, 2016

In 1993 the American Academy of Audiology (AAA) held their 5th annual convention in the Arizona desert. The official attendance for the meeting was reported to be 2,300. Move the clock 23 years and a new generation of audiologists joined a stalwart group of AAA founders, exhibitors, clinicians and countless others – some 6,000 attendees in total – to celebrate audiology.

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Given the hundreds of learning labs, exhibitor courses, featured sessions and scientific podium presentations, there is much to celebrate – audiology has never had a more dynamic & diverse presence in academia, industry, healthcare and commercial business.

Yet, in conversation with some conference-goers, a pall may have been cast over this meeting.

 

Domino Effect

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Although more than 170 exhibitors showcased the latest technology in the profession, several industry behemoths were conspicuously absence from the expo floor. This list includes Starkey and Amplifon, who have not exhibited in a few years. In 2016, they were joined by GN Resound and Unitron.

According to sources who wish to remain anonymous, other key industry players are contemplating a similar strategic move and leaving their exhibit space in 2017.

 

Even though Oticon, Signia and Widex had busy booths this year, the withdrawal of major industry players may signal a domino effect in how industry incumbents market their new products, perhaps now preferring a more direct, local approach with their customers, rather than the large splash coinciding with the annual AudiologyNow event.

 

Looming Changes Ahead?

 

In addition to the absence of key players on the show floor, several sessions alluded to the impact of the  PCAST’s recommendations to create a new, Basic category of direct-to-consumer hearing aids (along with three other recommendations that could essentially deregulate the industry) might have on the profession of audiology.

In what is sure to be an arduous process, the FDA is scheduled to hold on April 21st, a full day workshop: Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids.

Thursday’s conference will be simulcast at https://collaboration.fda.gov/gmp042116/.  Readers are encouraged to view the session in real-time.

 

Déjà vu All Over Again

 

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David Kessler

Veteran audiologists may recall that the 5th Annual AAA convention in Phoenix occurred a few months before another pivotal US Government meeting concerning the regulation of hearing aids.

It was in 1993 that then FDA Commissioner David Kessler spearheaded a congressional inquiry that lead to significant changes in hearing aid product claims. A transcript of the September, 1993 congressional meeting involving Dr. Kessler, along with several witnesses from ASHA, IHS and AAO (apparently AAA was too young of a group to be invited) participated in the proceedings.

 

Reading the transcripts from the 1993 proceedings is a reminder that many of the key issues audiologists and other stakeholders currently face have remained largely unchanged.

 

Below is the agenda for the April 21st meeting.

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GMPs for Hearing Aids Agenda

 

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*title image courtesy consumerproductmatters

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