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A key challenge in developing a fully implantable hearing aid is designing a microphone that will work effectively under the skin. Bedoya notes that the properties of human skin change throughout the day with the user’s hydration levels and other factors, and he hinted that the company is developing technology to detect those changes and adjust to them. He also points out that the location of the microphone behind the ear is an important factor that can be fine-tuned.

Outside experts see significant progress being made in implantable microphone design. Joseph Roberson, an ear surgeon and the CEO of the California Ear Institute, in Palo Alto, CA, says, “I listened to a good-fidelity musical signal received by an implantable microphone positioned under half an inch of raw steak.” The functional outcome of the Otologics device, he says, is “roughly equivalent to existing visible external technology.”

But critics question whether Otologics can match the performance of conventional hearing aids, and they ask whether the new device is worth the surgical risk and the cost ($19,000 in Europe, excluding the cost of the surgery, versus $6,000 for a high-end conventional aid; the device is available in Europe but still in clinical trials in the United States). Gerald Loeb, a professor of biomedical engineering at the University of Southern California, argues that implanted hearing aids should outperform conventional ones before they can be considered worth the extra cost and risk. He also questions the emphasis on making an invisible device: “How big an issue is it to have a little appliance on your ear when the whole world is walking around with cell-phone headsets and iPod earpieces?”

Nonetheless, the phase I study concluded that the Otologics device “serves as a viable treatment alternative for moderate to severe sensorineural hearing loss.” Bedoya says that the company is addressing the problems found by the study and preparing for phase II trials, in which 90 subjects will be tested with a revised device.

Roberson suggests that the device may be most suitable for “alpha adopters … who are motivated to keep their use of a hearing device a private matter, or those who are intolerant of standard hearing-aid technology.” Silicon Valley executives, he thinks, may be first in line.

Michael Chorost is the author of Rebuilt: How Becoming Part Computer Made Me More Human.

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Credit: Otologics

Tagged: Biomedicine, implant, radio, magnets, hearing

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