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. CCI Newswire
