Rest assured, the FDA is policing the companies that manufacture hearing aids. This is very good to know. Makers of hearing aids need to know that they are being monitored and held to a very high standard. These are expensive and complicated devices that can damage hearing and health if not built 100% as ordered by the FDA.
A good example of a company trying to break the rules and being caught occurred in California in 2008. The FDA had approved the parts and process being used by Advanced Bionics. However, they learned that the company had changed vendors for a few of the key pieces of the hearing aid without going to the FDA for approval. Clearly Advanced Bionics hoped to save costs and not draw the attention of the FDA.
It didn’t work out well for the company. The FDA caught them and fined them well over one million dollars. This is huge becasuse not only does it punish this company it also sends a message to all hearing aid makers: We are the FDA and we are watching you. Step out of line and you will be whacked!
Nice work FDA – thank you from Hearing Aids 1000.