![]() 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.Įvery hearing loss is unique, and the expertise and care of the hearing professional are essential for the best patient outcomes.
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