Hearing aids are among the least satisfying of technologies for consumers in the medical device sector. They don’t work very well, the hard-of-hearing say, or work only with large levels of discomfort and distortion.

On the bright side, this keeps driving innovation in the sector.

In the most recent permutation of the technology,Boston Scientific (Natick, Massachusetts) last week reported FDA approval of its new Harmony HiResolution bionic ear system, which the company has designed to render, among other benefits, the nuances of music accessible to those who are severely or profoundly deaf.

The two-part system consists of a cochlear implant, an internal component, as well as an external component, behind-the-ear.

The difference in this system compared to competitors is that the Harmony delivers 120 spectral bands, whereas existing systems offer only up to about 22 spectral bands using microelectronic circuitry and software, Eric Olson, a Boston Scientific spokesman told Medical Device Daily. Those spectral bands are similar to channels one might find on a radio or TV, and the more channels, the more clarity in sound a user will get from the system, he said.

“The Harmony System represents the next generation of cochlear implant technology,” said Jeff Greiner, president of Boston Scientific’s Neuromodulation Group. “We have brought together unprecedented advancements in science, design and functionality for the user – furthering our commitment to restoring hearing and improving quality of life for those living with hearing loss due to permanent inner ear or auditory nerve damage.”

Boston Scientific’s Neuromodulation Group was formed with its acquisition of Advanced Bionics (Valencia, California) in 2004, first announced in June of that year, for $740 million in cash, plus future milestones (Medical Device Daily, June 2, 2004).

The Harmony System will replace the company’s previous Auria product, which also used the “bionic” term — so the term has been associated with the Advanced Bionics products, now Boston Scientific’s, for some time, Olson said.

Olson said the Harmony HiResolution bionic ear system is a “new platform” for the company, which is involved in continuous R&D.

“This isn’t your typical hearing aid for someone who can’t hear his wife over the dishwasher,” Olson told MDD. “These are folks that have had permanent damage to the inner ear and are severely and profoundly deaf, essentially people that can’t hear.”

Designed to enhance music appreciation and improve hearing in a variety of difficult listening environments, Olson said the system should enable users to distinguish musical instruments and tones and melodies more effectively than existing devices. Overall, the higher resolution, or clarity, is expected to provide “a more natural representation” of sound to help improve patient performance.

“With the new Harmony system, we are able to actively steer electrical currents with a high degree of accuracy, increasing the number of spectral bands from 16 to 120,” said Greiner. “We are attempting to guide precise pitch information into the cochlea by taking advantage of surviving neural populations to help increase the user’s ability to hear in noisy environments and to better appreciate the intricate sounds of music.”

Cochlear implants, which have been available for some time, enable users to access soft whispers and loud sounds without adjusting dials or controls with Harmony’s “CD-quality processing,” the company said.

According to clinical evaluation of the Bionic ear, about 80% of the subjects reported a “strong preference” for the Harmony sound processor with HiRes Fidelity 120, with most noting that they could hear speech with improved clarity and/or that environmental sounds were clearer and easier to distinguish. The system is expected to help also with speaking over the telephone.

Olson said that potential users will be able to use both or either of the components of the Harmony system. Those who already have a cochlear implant could use the external component only, or they could choose to have another surgery to have the Boston Scientific internal component replace their existing cochlear implant.

In addition to winning FDA approval, the Harmony system recently received approval from Health Canada and the CE mark in Europe, the company said.

The Harmony system is expected to be available in early 2007, with otolaryngologists being the target market.