Envoy Medical’s Esteem hearing-aid implant is a revolutionary new approach to hearing restoration. Completely unlike any other hearing aid or cochlear implant on the market, it provides significant functional and cosmetic benefits: no device is required for the outer ear, so sound is not obstructed as it passes through the ear canal; there is no artificial amplification of sounds before they reach the ear drum, which means sound is processed naturally through the outer ear; and the implanted system is completely invisible.
FDA approval of the patented system in 2010 cheered Envoy Medical’s all-star cast of investors, who so far have anted up $140 million in capital. But now it’s time to answer the big question, which is whether the Esteem invisible hearing aid will correct damaged hearing any better than the latest generation of less expensive and less invasive digital hearing aids. At a reported cost of $30,000, the implant is five-to-ten times the cost of today’s highest-end in-ear digital hearing aids, so the Envoy’s Esteem hearing system will have to prove it’s got a superior value proposition as it makes its way into the marketplace in 2011.
The Envoy Medical Esteem implant eliminates the need for a microphone or speaker by implanting a sensor in the middle ear that captures sound waves flowing naturally through the outer ear and eardrum and to the incus, one of the small bones in the middle ear that transmit sound to the cochlear hearing nerves in the inner ear. A digital sound processor implanted in the skull behind the ear receives and conditions the signals, returning them to a driver in the middle ear that stimulates the spur-shaped stapes bone to deliver properly amplified signals into the cochlea. The company’s excellent video animation shows how the system works.
According to the company, initial performance results are impressive. In an Envoy Medical video, Dr. Michael Glasscock, an ear surgeon who was among the first to have the Esteem system implanted behind both ears, says clinical studies of early users resulted in a 45 percent improvement in word recognition over their experience with regular hearing ads. As the Esteem implant finds a broader market in 2011, it should start to become clear how well those initial strong results hold up, and how broad a range of patients’ needs the implant will serve.
In the meantime, Envoy Medical seems poised to take its place among other major suppliers of hearing implant systems, including cochlear implant makers Cochlear Ltd. and Advanced Bionics. As with any invasive medical procedure, there are risks to auditory implants. Cochlear implants have experienced quality and performance issues over the years. But unlike cochlear implants, which thread a tiny filament through the cochlea in the inner ear, the Envoy Medical system only engages the middle ear, which is more familiar territory for ear surgeons.
One of Envoy Medical’s all-star investors — Starkey Laboratories of Minnesota, one of the world’s six largest hearing-aid suppliers — provides a measure of how seriously makers of traditional hearing aids are taking the new hearing implant technologies by investing in them. 2011 will give an indication of how necessary it will be for those hearing aid makers to hedge their bets.