Approximately 30 million adults in the United States have some degree of hearing loss. Hearing loss can have a negative effect on people’s lives. However, hearing loss need not restrict your daily activities. Properly fitted hearing aids and hearing rehabilitation can help in many hearing situations.
With the improvement of Americans’ lives in mind, the FDA issues a final rule establishing over-the-counter hearing aids to improve access to safe, effective and affordable hearing aids for millions of Americans.
In August 2022, the FDA finalizes the historic rule allowing millions of Americans access to over-the-counter hearing aids.This action allows consumers 18 years and older with mild to moderate perceived hearing loss to purchase hearing aids directly from stores or online retailers without the need for a medical examination, prescription, or fitting adjustment by a speech-language pathologist.
new category: over-the-counter (OTC) hearing aids
This new OTC hearing aid category will expand access to high quality health care, reduce health care costs for the American public, and promote Competition in the American Economy.
The final rule aims to encourage competition and facilitate the sale of safe and effective OTC hearing aids in traditional retail stores or online nationwide, giving consumers with mild to moderate perceived hearing loss better access to devices that meet their needs and are less expensive than current options.
Deadline: following publication in the Federal Register.
60 days: After publication in the Federal Register.
240 days: Manufacturers of hearing aids sold before the effective date of the final rule will, after publication, be required to comply with the new or revised requirements.
New approvals: For hearing aids that were not offered for sale before the effective date, compliance with the new or revised requirements must be achieved prior to marketing the device, including obtaining 510(k) clearance, if applicable.
We are a global consulting firm Headquartered in Boston Massachusetts USA that provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical and medical device companies worldwide to register their product with the Food and Drug Administration (FDA) the local Health Authority (HA)
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.