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InSound Medical, a medical-device startup in Newark, Calif., wants to let people with hearing loss regain that sense without having to wear a conspicuous hearing aid. Instead of clipping around the ear or fitting precariously into the opening of the auditory canal, the company’s Lyric hearing aid is implanted deeper into that canal, where it can remain for up to four months.
The device uses an extended-wear battery and is implanted in a non-surgical procedure in a doctor’s office. Every two to four months, a Lyric device must be extracted and replaced with a new device. InSound sells Lyric on a “subscription” model, in which patients buy a year’s worth of devices at a time. (That’s a company graphic of the device below.)
InSound just raised $11 million in an extension to its fifth round of funding, according to Dan Saccani, the company’s CFO. Investors in the round included De Novo Ventures, J&J Development and CMEA Ventures.
The Lyric was cleared by the FDA in late 2002, although InSound didn’t launch it until last year, Saccani told me. During that time, it underwent a name change — it was originally called the InSound XT — and additional engineering development. The Lyric is currently in limited release in the San Francisco Bay Area.
A five-year delay between approval and product launch is pretty unusual in my experience of the medical-device industry, although I’d be the first to admit I haven’t fully grasped all of its ins and outs. The XT received fast FDA approval because it’s not a surgical device, Saccani said, adding that continuing to develop a product following FDA approval “happens all the time” in the industry.
I’m apparently not the only one a bit baffled by this situation. This 2003 article in Ear, Nose and Throat Journal also describes the San Francisco Bay Area as “the first test market for the InSound XT in 2003.”
InSound doesn’t disclose the Lyric’s price, either — in a FAQ for patients on its Web site, the company replies to the sensible question of cost by blathering on about the revolutionary nature of the device and then suggests that patients “[t]alk with your ENT physician and audiologist to discuss pricing and payment options.” (ENTs are ear, nose and throat doctors.) Saccani explained that because the Lyric is only available on a limited basis, the company is keeping pricing information “close to the vest.”