Advances in implantable devices for hearing loss

By Deborah Kotz, Globe Staff

When Maxine Kessler lost complete hearing in one ear four years ago, she thought about getting an implantable device to restore her hearing, but she didn’t want a rod surgically embedded in her skull that would protrude from the skin behind her ear. For the past few months, she’s been able to hear again from both ears thanks to a new nonsurgical device that picks up sound vibrations from her deaf ear and transmits them to her good ear via a device that fits inside her mouth around her back teeth.

“I’m very happy with it,” said Kessler, whose sudden hearing loss was caused by an autoimmune disease. “I can hear very well from that ear, but I can’t tell where the sound is coming from. If someone yells my name, I look around everywhere to see where the person is.”

Unlike hearing aids which amplify sound and typically aren’t covered by insurance, the device, called SoundBite, is covered by some insurance plans, though usually with a copayment. Kessler said she laid out $600 for the fitting procedure and device and has yet to hear from her insurance company, Harvard Pilgrim, about whether she’ll get a refund or will be billed for an added amount. She works as an education director at Boston Medical Center where she had the procedure. United Healthcare states on its website that it considers the device experimental and not eligible for coverage.

Dr. Kenneth Grundfast, who fitted Kessler with the device and is chief of otolaryngology at BMC, said he’s had good results with most of his patients. “Some complain about hearing feedback if they use a Bluetooth device, and they tell me it takes time to get used to having the device in their mouth, that they can feel it with their tongue.”

Grundfast said there’s been a trend toward developing less conspicuous hearing devices for those with impaired hearing due to aging or complete hearing loss, which may result from genetic factors, autoimmune conditions, or illnesses.

Implantable hearing aids are in various stages of clinical trials with one -- called Esteem -- that received recent approval by the US Food and Drug Administration. These can replace traditional hearing aids; they’re inserted in the middle ear and are purported to reduce many of the problems associated with hearing aids placed in the outer ear, like feedback, distorted sounds, ear canal discomfort, and lack of effectiveness due to wax buildup.

But costs are significant for the device and procedure -- about $25,000 -- which usually isn’t covered by insurance since it’s fairly new with unproven efficacy in large clinical studies. Patients with the device can’t have MRI imaging and about 5 percent of find that the device doesn’t work well for them to restore hearing.