{"id":55534,"date":"2022-09-12T16:06:57","date_gmt":"2022-09-12T20:06:57","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-issues-final-rule-for-otc-hearing-aids\/"},"modified":"2022-09-12T16:06:57","modified_gmt":"2022-09-12T20:06:57","slug":"fda-issues-final-rule-for-otc-hearing-aids","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/es\/fda-issues-final-rule-for-otc-hearing-aids\/","title":{"rendered":"FDA Issues Final Rule for OTC Hearing Aids"},"content":{"rendered":"

On August 17, 2022, the U.S. Food and Drug Administration (FDA) issued a\u00a0final rule\u00a0establishing a new over-the-counter (OTC) category of hearing aids for consumers with perceived mild to moderate hearing impairment. The rule, effective October 17, 2022, will allow consumers to purchase hearing aids from online retailers and stores without a prescription, medical exam or fitting adjustment. This action is intended to offer more affordable and accessible hearing aid options for U.S. consumers.<\/p>\n

Read on for background on the final rule and compliance deadlines for OTC hearing aid manufacturers.<\/p>\n

\n

Get assistance with FDA compliance.<\/h3>\n

Registrar Corp\u2019s Regulatory Specialists help companies comply with FDA requirements.<\/p>\n

For assistance with FDA regulatory requirements, call: +1-757-224-0177, email: info@registrarcorp.com<\/a>, or chat with a Regulatory Advisor 24-hours a day: regstaging.wpengine.com\/livechat<\/a>.<\/p>\n

Get Assistance<\/a><\/p>\n<\/div>\n

Creation of the OTC Hearing Aid Final Rule<\/strong><\/p>\n

FDA issued the proposed rule to create a category of OTC drugs for hearing aids on Oct. 20, 2021 in response to President Biden\u2019s July 2021 Executive Order\u00a0on Promoting Competition in the American Economy. The order required FDA to initiate action within 120 days that would allow hearing aids to be sold over the counter. Congress passed similar legislation in 2017 that required FDA to create a category of OTC hearing aids, but the legislation was not carried out completely at the time.<\/p>\n

FDA anticipates the rule will increase innovation and competition among hearing aid manufacturers and lower hearing aid costs for consumers. FDA intends to assure OTC hearing aids are safe and effective through implementation of the rule, which applies to \u201ccertain air-conduction hearing aids intended for people 18 years of age and older who have perceived mild to moderate hearing impairment\u201d. Hearing aids that do not meet the requirements for the rule\u2019s OTC category, such as those intended for severe hearing impairment, will be defined as prescription medical devices.<\/p>\n

FDA incorporated several changes from the proposed rule to construct the final rule<\/a>, including lowering the maximum sound output to minimize hearing loss from excessive volume, revising how deep hearing aids can be inserted in the ear canal, requiring all OTC hearing aids to include a volume control that users can adjust, and simplifying labeling phrasing for easier consumer comprehension.<\/p>\n

In addition, the OTC hearing aid final rule accomplishes the following:<\/p>\n