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Official Statement from Speech and Hearing BC (SHBC) FDA Releases Final Rule for OTC Hearing Aids

On August 16, 2022, the United States Food and Drug Administration (FDA) released its final rule for over-the-counter (OTC) hearing aids. This historic rule established a new regulatory category for OTC hearing aids by allowing direct purchases from stores and online retailers without needing an audiologist’s medical exam or audiological evaluation, prescription, or verification.

While this ruling will increase the availability and affordability of hearing aids for adults aged 18 years and older with perceived mild to moderate hearing loss, it eliminates the diagnosis process. Comprehensive audiological assessment, which includes diagnosis of the type, degree, configuration and potential asymmetry of the hearing loss before and in conjunction with hearing aid fitting and aural rehabilitation, is critical.

The diagnosis process is supported by the expertise of audiologists, ensuring that hearing care is individualized, safe, and effective. Without this expertise and possible audiological findings, patients could go on with undiagnosed medical issues, such as certain types of brain cancer.

The Canadian government has not instigated a proposal to follow suit with its regulated class of OTC hearing aids. However, SHBC will work with Speech-Language & Audiology Canada (SAC) to monitor guidance from Health Canada and provincial/territorial regulatory bodies related to OTC developments in Canada.

Speech and Hearing BC (SHBC) will continue to support its audiology members and advocate on their behalf regarding OTC hearing aids, particularly should regulatory changes occur in Canada.

About SHBC: Speech and Hearing BC (SHBC) is a not-for-profit association with more than 1200-member speech-language pathologists and audiologists in British Columbia who believe in optimal communication and swallowing health for all British Columbians. To learn more, visit:

Jayme Wilson