“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.”
-Brandon Sawalich, President & CEO of Starkey
