New draft guidance for hearing aids manufacturers released by US medical device regulators

New draft guidance has been released by the US medical device regulators, which is related to requirements for manufacturers and marketers of hearing aids and personal sound amplification products (PSAPs). According to the new draft, although the two devices have similar use, there are some important differences between the two types of devices, which should be understood.
Simply said, both hearing devices are aimed at enabling the user to hear well. However, the formal hearing aids are prescription products and OTC sound amplifiers can be commonly used by those willing to amplify their hearing. It is important to make the difference and the purpose of use clear. Also, as the intended use is different, both the devices are subjected to a different set of regulatory guidelines.

According to the FDA, the intended use can be established means of labeling. As general situations that indicate hearing problem include difficulty in listening to conversations, television or door bell are common. FDA says that products with such claims and indications should not be considered as PSAPs and authentic products need to have proper FDA approval. View full draft guidance