Eden Prairie, Minnesota (August 17, 2022) – Starkey President and CEO, Brandon Sawalich, has issued a statement in response to the OTC Hearing Aid FDA ruling. “We thank the FDA for listening to countless hearing healthcare professionals, lawmakers and patients around reducing output limits on over the counter (OTC) hearing aids, thereby acknowledging that patient safety, satisfaction, and effectiveness of these devices are paramount. As a company that has engineered and manufactured medical devices for over 50 years, we still have concerns with the final OTC rule, including the decision to not include a gain limit and to ignore the concerns of nearly every state’s attorney general around preemption and regulation of these devices.
Every hearing loss is unique, and the expertise and care of the hearing professional are essential for the best patient outcomes. Since 1967, Starkey has been committed to further opening access to hearing healthcare while putting the patient first, and it is our hope that this new category of OTC hearing aids will help more Americans reconnect with the world around them while keeping patient satisfaction of hearing aids at its current all-time high.”
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Starkey is a privately held, global hearing technology company headquartered in Eden Prairie, Minnesota. Owned by Bill Austin since 1967, Starkey is known for its innovative design, development and distribution of comprehensive digital hearing systems. Led today by President and CEO Brandon Sawalich, Starkey has more than 5,000 employees, operates 28 facilities and does business in more than 100 markets worldwide. Learn more at starkey.com.