Lots of people suffer from selective hearing loss that allows them to hear low frequency sounds quite well, while the high pitch is severely limited. This is normally due to damaged cochlea and traditional options, like hearing aids and cochlear implants, often don’t do a sufficient job of helping such people hear the world around them. A new, first of its kind system, that combines an implant and a hearing aid into one, has just been approved by the FDA for people with severe or profound sensorineural hearing loss of high-frequency sounds in both ears.
The hearing aid component of the Nucleus Hybrid L24 Cochlear Implant System from Cochlear Ltd. transmits processed audio to the implant that in turn stimulates the cochlea via a set of electrode leads. This creates a sense of hearing in the higher frequencies, while the hearing aid does more traditional sound processing and amplification for the lower frequencies.
The system also includes a couple optional control devices that allow for tuning of the system to adjust its audio processing and neurostimulation for individual patients
From the FDA’s announcement:
The agency evaluated a clinical study involving 50 individuals with severe to profound high-frequency hearing loss who still had significant levels of low-frequency hearing. The individuals were tested before and after being implanted with the device. A majority of the patients reported statistically significant improvements in word and sentence recognition at six months after activation of the device compared to their baseline pre-implant performance using a conventional hearing aid. The device also underwent non-clinical testing, which included the electrical components, biocompatibility and durability of the device.
Of the 50 individuals participating in the study, 68 percent experienced one or more anticipated adverse events, such as low-frequency hearing loss, tinnitus (ringing in the ear), electrode malfunction and dizziness. Twenty-two developed profound or total low-frequency hearing loss in the implanted ear, six of whom underwent an additional surgery to replace the Nucleus Hybrid L24 Cochlear Implant System with a standard cochlear implant.
While the risk of low-frequency hearing loss is of concern, the FDA determined that the overall benefits of the device outweigh this risk for those who do not benefit from traditional hearing aids.
Here’s more about the system from last year’s FDA presentation by Christine Menapace, Vice President Clinical, Quality and Regulatory Affairs, Cochlear…