By David H. Kirkwood
LOS ANGELES–Last month, The Good Ear introduced the Better Hearing iPhone app. The app, which costs $4.99, contains Threshold Sound Conditioning (TSC), a proprietary technology that the company says can actually reverse users’ hearing loss. (For more, see my earlier post on Hearing News Watch.)
Just a few weeks later, the Los Angeles-based company announced that it has received clearance from the Food and Drug Administration (FDA) to market a hearing aid that also contains TSC.
However, while the newly approved hearing aid is called the TSC-i48, the FDA did not determine (nor was it asked to determine) if it was capable of improving wearers’ unaided hearing. Instead, the agency approved the device as an air conduction hearing aid, using the 510(k) process. That means that it found the product to be “substantially equivalent” in safety and effectiveness to other air-conduction hearing aids that it has previously approved.
Kihong Bae, CEO of The Good Ear, told Hearing News Watch that his company hopes to begin selling the TSC-i48 in this country near the end of this year or in early 2013. It also plans to introduce it in China, probably later in 2012.
Bae said that the instruments will be sold through audiologists and hearing aid specialists, at least initially. He added, “We are also thinking about direct-to-consumer (online) distribution.” Prices for the TSC-i48, which currently comes in only the behind-the-ear style, have not yet been set, but, said Bae, “Most likely it will be priced like a regular hearing aid.”
The new hearing aid is currently undergoing clinical trials conducted by Stanford University/Palo Alto Medical Foundation. If these trials demonstrate that Threshold Sound Conditioning can, as The Good Ear contends, reduce hearing loss caused by damaged hair cells, the company will seek FDA approval to make this claim for the TSC-i48. Until then, Bae said, “We cannot openly advertise it as something that will ‘improve hearing’. We plan to market it as a hearing aid with a feature called TSC.”