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SoundBite device helps restore hearing in one-sided deafness

TAMPA

Put a high-quality earplug firmly in one ear. Then go about your day as usual.

Don't be surprised if you find it frustrating, embarrassing, stressful and exhausting. That's how it was for Sandy Alfonso of Tampa in 2009 when she lost hearing in her left ear following a severe bout of shingles.

The hearing loss affected everything from her usual morning routine, driving and work performance to going out with friends. Even walking became a trial, because one-sided hearing put her off balance. She had to quit her management job in the health insurance industry and felt increasingly isolated.

"I was really starting to withdraw from social functions and situations because I couldn't hear what anybody was saying," said Alfonso, now 68. "Life was just not the same at all. It felt like half my head was missing."

Standard hearing aids didn't help. They work best for mild to moderate hearing loss, when all you need is a volume boost. Alfonso hears nothing in her affected ear. Then her husband read on the Internet about a device called the SoundBite Hearing System. It uses the teeth and surrounding bones to conduct sound from the bad ear to the good ear, so users perceive sound as coming from both sides.

Bone conduction hearing devices, as they are known, have been around for years. But most require surgery to implant a small magnet or piece of metal beneath or in the scalp. Patients usually have to attach a processor behind the ear that can't be hidden by short hair.

The SoundBite requires no surgery. Patients wear a small behind-the-ear unit, or BTE, which attaches to a tiny microphone placed in the affected ear canal. It sends sound to a receiver attached to a custom miniretainer that fits over two back teeth, usually on the opposite side of the head. Sound vibrations travel through the teeth and surrounding bones to the functioning inner ear where they are perceived as natural sound. The in-the-mouth unit, or ITM, remains in place while eating and drinking but, like the BTE, is easily removed for recharging. It only works for people like Alfonso who have one-sided deafness, and good function in their other ear.

"The status of your hearing in your other ear, your good ear, is important," said audiologist Jeffrey Clark, who has fitted more than 20 patients, including Alfonso, with a SoundBite system. "The hearing in that ear must be normal or very near normal in order for the SoundBite to work."

Clark said patients who are not candidates for SoundBite have other options, though most involve surgery. The cochlear implant, a sophisticated electronic device that gives a sense of sound (though not normal hearing) to the profoundly deaf is emerging as a possible remedy for single-sided deafness.

Cost is often the deciding factor. Hearing aids frequently cost several thousand dollars; implanted devices cost tens of thousands of dollars. Few health insurance plans cover hearing aids, but some may provide partial coverage for implantable devices.

The SoundBite was FDA-approved in 2011 as a prosthetic device, not a hearing aid, because it doesn't amplify sound.

Sonitus, the Silicon Valley company that makes SoundBite, works directly with insurance companies to obtain coverage. It took a year for Alfonso to get approval from her carrier, which covered half the $6,800 cost. She also paid $150 to have the dental appliance made. That, in addition to charges for fittings, adjustments, and other audiologist services, may drive final costs for some patients closer to $8,000 or more.

"If I had had to, I would have paid the full amount in a minute," Alfonso said. "It has been so good. Like night and day the minute he put it in my ear. He whispered something in my left ear and I knew exactly what he said. It was absolutely fantastic."

But for many, the cost of the SoundBite is a barrier that can't be overcome, said Dr. Loren Bartels, director of the Tampa Bay Hearing and Balance Center and professor of otolaryngology at the USF Morsani College of Medicine.

"In the majority of cases insurance pays nothing for hearing aids and if they do, a $1,000 to $2,500 allowance is much more typical," Bartels said.

He has recommended SoundBite to several patients who've been unable to afford it. "I think they have a good product and it bothers me that getting insurance coverage is so difficult."

Much as the SoundBite has improved her life, even Alfonso says there are times when she's in a really noisy room and can't hear conversations as she used to. Still, she's okay with 97 to 98 percent hearing.

"It's the best thing that's happened to me since this bad illness hit," she said.

Her last bit of advice: "Be sure to tell people to get the shingles vaccine."

Irene Maher can be reached at imaher@tampabay.com.

SoundBite device helps restore hearing in one-sided deafness 06/14/14 [Last modified: Thursday, June 19, 2014 12:34pm]

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