Patients with single-sided deafness or asymmetric hearing loss often have associated problems like identifying where sounds originate, maintaining balance, speech recognition and hearing in complex noise environments.

Existing treatment options, which include hearing aids or bone conduction devices, often fail to address these issues because they generally only serve to reroute sound signals from one ear to the other.

One option that has largely been out of reach for patients has been cochlear implants, which have predominantly been used only for individuals with profound hearing loss in both ears.

However, that status quo may be changing. Last week, the FDA approved an expanded indication for single-sided deafness (SSD) and asymmetric hearing loss (AHL) for MED-EL’s Synchrony cochlear implant device opening up the potential for millions of new patients to access the technology to improve their hearing health.

The regulatory decision, which represents the first time in the U.S. cochlear implants have been approved for single-sided deafness, came without any necessary changes in the technology behind the device or the implantation process.

MED-EL is a privately-owned hearing device company based in Innsbruck, Austria that was founded by Ingeborg and Erwin Hochmair, two early innovators in the field of cochlear implants. The company’s U.S. branch is headquartered in Durham, North Carolina.

Cochlear implants involve a procedure that put an electrode deep inside the spiral shaped cochlea in the inner ear to directly stimulate the auditory nerve. The implant is paired with an external audio processor that looks similar to a hearing aide and is able to pick up sound and convert it to electrical pulses which are “heard” by the brain.

Raymond Gamble, the president and CEO of MED-EL USA, grew up with a father who suffered from single-side hearing loss and was able to see first hand how the condition impacted his day-to-day experiences.

“I saw how it increased cognitive load, made him more isolated and negatively affected his quality of life. It was a big reason why I became an audiologist in the first place,” Gamble said.

The new indications vastly expand the proportion of patients who could receive benefit from a cochlear implant device. According to a study published last year, around 1.5 percent of Americans have moderate or worse single-side hearing loss, which translates to roughly 4.9 million adults in the country. Among the population with any level of single-sided hearing loss, only 2 percent were using hearing aids.

Synchrony was cleared by the FDA for with SSD and AHL patients five years or older who have profound sensorineural hearing loss in one ear and who have normal to moderately severe sensorineural hearing loss in the other ear, with with a difference of at least 15 dB in pure tone averages between ears. Before implantation with the device, patients must show low subjective benefit from existing one-sided hearing aids.

Sensorineural hearing loss is the most common form of hearing loss and is caused by damage to the inner ear or the auditory nerve.

The FDA based their decision on a clinical trial conducted by University of North Carolina researchers, which was able to show improvement in speech understanding scores, sound source location and patient satisfaction from SSD and AHL patients who were fitted with MED-EL’s implant.

Among the SSD patients studied in the trial, MED-EL’s device resulted in patients able to improve their average scores when repeating single words in quiet from 4 percent before surgery to 55 percent after 12 months of listening with the implant.

“In the way we designed our study we were very deliberate in the design of our protocol to test for binaural hearing,” said Margaret Dillon, the director of Cochlear Implant Clinical Research at the University of North Carolina.

“We were very selective choosing the device, the mapping procedures and shaping post-operative care to make sure we were testing for spatial hearing and sound localization.”

She said that the researchers decided on using MED-EL’s product because of the long electrode array, which helps to better allow for a range of frequencies to be picked up by the device.

Dillon said the need for the expanded indication for cochlear implants for single sided deafness was apparent by the patients she saw which were willing to pay out-of-pocket for the procedure because of the lack of effective treatment options available. At her clinic, Dillon said the procedure would run between $30,000 and $40,000.

As in the case of many healthcare innovations, reimbursement remains the biggest obstacle to expanding access to new patients, but Gamble positioned the expanded regulatory approval as “an important first step.”

“We’ll be aggressively talking to private payers and state Medicaid organizations. This regulatory clearance is important because it eliminates the initial barrier of payers refusing coverage because the treatment itself is not FDA approved,” Gamble said.

Picture: MED-EL