FDA Backs Up Cochlear™Nucleus® Hybrid™Approval

Cochlear Nucleus Hybrid Implant

Last month implantable hearing solutions expert, Cochlear Ltd., gained U.S. FDA approval for its Cochlear™ Nucleus® Hybrid Implant System. Now the FDA has issued its own information summary about the device.

Background

Cochlear says its Nucleus Hybrid Implant is designed to help people who may hear a little but are still missing a lot, even with their hearing aids. It works in effect by amplifying the low-pitched hearing a person does have while restoring access to the high-pitched hearing they’ve lost. People who are candidates for the technology no longer have to worry about straining to hear with their hearing aids as the system will allow them to maximize their hearing in all frequencies.

The Nucleus Hybrid System is designed to deliver patients superior quality and clarity of sound in even the most difficult hearing situations, especially hearing in noisy environments. It is supported by robust clinical evidence which showed that Nucleus Hybrid System recipients heard on average two times better in both quiet and in noise than with hearing aids. Additionally, those recipients reported a ten times increase in their overall hearing satisfaction than with hearing aids.

Neither hearing aids nor cochlear implants are ideal for individuals who demonstrate normal to moderate low frequency hearing loss with a severe to profound sensorineural hearing loss in the high frequencies, more commonly known as a “ski-slope” hearing loss. With the new Nucleus Hybrid System, the treatment criteria is expanded further to include adults with more hearing in the low frequencies who have difficulty hearing simple words and sentences in noise, even with the most advanced hearing aids.

The FDA’s update states that the Hybrid L24 is intended for use in one ear by patients aged 18 years or older who obtain limited benefit from appropriately fit hearing aids in both ears and have typical preoperative hearing in a range from normal to moderate hearing loss in the low frequencies, with severe to profound loss in the mid to high frequencies. Candidates should have consonant nucleus consonant (CNC) word recognition score of between 10% and 60%, inclusively, in the ear to be implanted in the preoperative aided condition and in the other ear will be equal to or better than that of the ear to be implanted but not more than 80% correct. Furthermore, they should previously have undergone a suitable hearing aid trial, unless already appropriately fit with hearing aids.

The FDA provides details of the study results that supported its approval: Fifty subjects participated in a clinical study across 10 sites. On the average, the device improved speech recognition in both quiet and noisy listening situations, and most subjects experienced improvement. Subjects with better low-frequency hearing postoperatively tended to perform better. Nearly half of the subjects experienced a significant loss of low-frequency hearing, and six subjects (12%) were explanted and reimplanted with a traditional cochlear implant. For subjects who lost low-frequency hearing and retained use of the device, most benefitted from the electrical hearing provided.

Company comments

“The launch of the first of its kind Nucleus Hybrid System means that we have the opportunity to give people back what they’ve been missing with their hearing aids,” said Chris Smith, President of Cochlear Americas. “By amplifying low-frequency hearing and restoring access to high-frequency hearing, this innovative new hybrid hearing solution will help people regain the sounds of life that had previously been lost, and ultimately empower them to connect with others and live a full life. We look forward to expanding access to hearing and instilling hope in those who may be suffering without an effective solution.”

Physician comments 

“The clinical data supporting the FDA approval of the Nucleus Hybrid System is very encouraging as it shows superior hearing performance compared to acoustic amplification alone,” said J. Thomas Roland Jr., M.D., Lead Nucleus Hybrid System Clinical Investigator and Chair & Mendik Foundation Professor of Otolaryngology and Neurosurgery at NYU Langone Medical Center. “What this means is that we now have an effective solution that offers hybrid hearing to patients who may benefit from both electric and acoustic amplification, and that most patients will likely be very satisfied with the results.”

Customer comments 

“Although I can hear many low-pitched sounds, my hearing loss is in the high frequencies, which makes hearing my children and grandchildren extremely difficult,” said Ellen DeVoss, Nucleus Hybrid System recipient. “After years of wasting thousands of dollars on hearing aids and accessories and progressively retreating into a world of isolation due to my hearing loss, my audiologist told me I was a candidate for the Nucleus Hybrid System. I was skeptical at first, but now if I had to choose two words to describe the outcome of this experience they would be ‘miraculous’ and ‘life changing.'”

Since receiving my Nucleus Hybrid System, I was promoted to Office Manager at a very busy dental practice, I’m on and off the phone all day long and am in every hearing environment possible,” DeVoss concluded. “I can’t say enough about how the hybrid hearing solution from Cochlear has not only replaced a sense but given me my life back.”

Source: Cochlear Ltd., FDA

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