The Over the counter (OTC) hearing aid regulations issued by the FDA went into effect on October 17, 2022. The distinction between OTC or self-fit OTC devices does not appear to be clear, and in some cases deceptive. The flood of devices and claims further cloud the decision pathway for consumer and professionals. Amazon recently initiated a review of all devices on their site to ensure they have met the appropriate clearances and labeling as required under regulations. Several examples of correct labeling and claims, as well as those that are considered suspect are discussed. Examples of questions that both consumer and professionals should be asking when looking into OTC devices are discussed.
Upcoming Live Webinars
CEUs/Hours Offered: AAA/0.1 Intermediate; ACAud/1.0; ASHA/0.1 Intermediate, Professional; BAA/1.0; CAA/1.0; Calif SLPAB/1.0; IACET/0.1; IHS/1.0; Kansas, LTS-S0035/1.0; NZAS/1.0; SAC/1.0; TX TDLR/1.0 Non-manufacturer, TX-142-23-050
Under Review: Calif. HADB/1.0 Hearing Aid Related - Pending approval for non-audiologist hearing aid dispensers in California
- After this course, participants will be able to describe and discuss the FDA regulations for OTC devices and changes to hearing aid distribution.
- After this course, participants will be able to compare the facts and misconceptions regarding OTC devices.
- After this course, participants will be able to review hearing professional choices of OTC hearing devices and personal sound amplification devices (PSAP).
|5-15 Minutes||FDA regulations overview|
|15-25 Minutes||Classification of OTC devices|
|25-40 Minutes||Facts vs. Myths|
|40-50 Minutes||Guidelines for OTC devices|
Thomas A. Powers
Thomas A. Powers, PhD, is the Founder/Managing Member of Powers Consulting, LLC, providing management consulting to the hearing health industry. Dr. Powers serves an expert audiology consultant and strategic advisor for the Hearing Industries Association, limited partner in RemotEar, LLC, and Executive Consultant to Healthcare Technologies and Methods, LLC. Dr. Powers received his BS from the State University of New York at Geneseo, and his MA and PhD in Audiology from Ohio University.
Sponsor Disclosure: This Course is presented by AudiologyOnline, a Continued site.
Content Disclosure: This learning event does not focus exclusively on any specific product or service.
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American Academy of Audiology
AudiologyOnline is approved by the American Academy of Audiology to offer Academy CEUs for this activity. The program is worth a maximum of 0.1 CEUs. Academy approval of this continuing education activity is based on course content only and does not imply endorsement of course content, specific products, or clinical procedure, or adherence of the event to the Academy's Code of Ethics. Any views that are presented are those of the presenter/CE Provider and not necessarily of the American Academy of Audiology.
Australian College of Audiology
AudiologyOnline courses are approved for Continuing Education Points by the Australian College of Audiology. Automatic ACAud Approval Number 20000. This course is offered for 1 CEP.
American Speech-Language-Hearing Assn.
0.1 ASHA CEUs
British Academy of Audiology
This course has been accredited with 1 CPD point/s by the British Academy of Audiology.
Canadian Academy of Audiology
The Canadian Academy of Audiology (CAA) supports and assists its members in the attainment of continuing education towards an individual professional development plan as required by their Provincial Regulatory Colleges and Provincial Associations. Audiology Online is an approved provider of educational activities for CAA members. Each hour of activity may be counted as one Continuous Learning Activity Credit (or equivalent) as allowed by the applicable regulatory college or association.
California Speech-Language Pathology & Audiology Board
AudiologyOnline.com is approved by the California Speech-Language Pathology and Audiology Board as a Continuing Professional Development Provider, approval number PDP 267. This course may meet the requirements for 1 hours of continuing education credit for audiologists as required by the California Speech-Language Pathology and Audiology and Hearing Aid Dispensers Board. The responsibility for determining whether or not this specific course counts toward an individual's requirements for license renewal is up to the individual. Please refer to the CA state board rules regarding allowable topics and self-study limits: http://www.speechandhearing.ca.gov/licensees/ce_req.shtml
International Association for Continuing Education and Training
continued, LLC, DBA AudiologyOnline, is accredited by the International Association for Continuing Education and Training (IACET). continued complies with the ANSI/IACET Standard, which is recognized internationally as a standard of excellence in instructional practices. As a result of this accreditation, continued is authorized to issue the IACET CEU. continued, LLC, is authorized by IACET to offer 0.1 CEUs for this program.
International Hearing Society
This program is approved by the International Hearing Society and its educational committee, the International Institute for Hearing Instruments Studies. To learn more about earning IHS CE Credit, click here.
Kansas Department for Aging and Disability Services
Kansas Department of Health and Environment: Approved for 1 continuing education clock hours for Kansas licensed Audiologists by the Kansas Department for Aging and Disability Services. Long-Term Sponsorship number LTS-S0035.
New Zealand Audiological Society
This course is offered for 1.0 Continuing Education points through the New Zealand Audiological Society.
Speech-Language & Audiology Canada
Clinically certified members of Speech-Language & Audiology Canada (SAC) can accumulate continuing education equivalents (CEEs) for their participation with AudiologyOnline. One hour of coursework equals 1 CEE. All SAC members are encouraged to participate in on-going education.
Texas Department of Licensing and Regulation
This course is approved by the Texas Department of Licensing and Regulation for 1 contact hour(s) for Hearing Instrument Fitters and Providers. No more than 10 contact hours per renewal period may be earned from an approved online continuing education course offered by an approved continuing education sponsor. No more than 5 contact hours per renewal period may be earned from an approved continuing education course offered by an approved manufacturer continuing education sponsor.