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.

 

COMPANY’S PLANS

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.”

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2 Responses to FDA okays hearing aid with technology designed to reverse sensorineural hearing loss

  1. Marsha says:

    It would be interesting to find out how many people show signs of improved hearing after use for a period of time.

  2. Dan Schwartz, Editor, The Hearing Blog says:

    Let’s look again at David’s original article titled “New iPhone app is said to improve users? hearing through targeted sound exposure” and the comments from two weeks ago:
    http://hearinghealthmatters.org/hearingnewswatch/2012/new-phone-app-is-said-to-improve-users-hearing-through-targeted-sound-exposure/
    Hearing aid professionals see longtime hearing aid users who are “power junkies” craving much more gain & output than would be apparent from the audiogram, “so they can hear” (i.e. we hear with our brain).

    My Questions:
    1) Is the operating principle behind this regimen basically a form of auditory therapy to “walk back” the brain where the ears have been exposed to constant loud sound, as one would find in a big city?

    2) On the hardware side, most likely they are using the “tinnitus therapy” functions available on some SoC’s: Is any “improvement” actually due to residual suppression of tinnitus?

    3) Assuming that there is an improvement in the detection of pure tones, will we see a corresponding improvement in speech discrimination scores &/or speech reception thresholds?

    The emphasis in audiology today is on “evidence-based” research: In my own opinion, this is not always the best way to go for hearing aid professionals, as we have to use intuition and common sense; but for this new principle I’d like to see some actual data… And a better explanation of the underlying neurobiological principles~