FDA Approves Envoy Medical’s Study for Fully Implanted Cochlear Implant
Envoy Medical received FDA approval to begin a study of its fully implanted CI, which uses the ear’s natural anatomy to capture sound.
Envoy Medical received FDA approval to begin a study of its fully implanted CI, which uses the ear’s natural anatomy to capture sound.
The American Cochlear Implant Alliance (ACI Alliance) announced that it has published the account of Michael Goldsmith, a COVID-19 survivor who was implanted with a cochlear implant after experiencing sudden single-sided deafness, a form of hearing loss.
He recently led an international group of hearing specialists who recommended that far more adults with moderate-to-severe or worse hearing loss should be offered the option to receive cochlear implants, which could improve hearing and quality of life.
The approval of the Cochlear Nucleus Kanso 2 Sound Processor, Nucleus 7 Sound Processor for Nucleus 22 Implant recipients, and Custom Sound Pro fitting software reflects Cochlear’s “ongoing commitment to innovation in hearing technology, providing access to smartphone connectivity and helping to improve hearing performance, and enhancing the cochlear implant fitting experience for hearing health professionals.”
Read MoreIf approved by the FDA, the Acclaim would be the “first-of-its-kind cochlear implant without any external components to offer unique benefits to users and hopefully increase cochlear implant adoption and user compliance across the globe.”
Read MoreThese models will ultimately enable development of next-generation programming strategies that rely on these computational simulations of implant performance to find programming settings that greatly improve sound quality for cochlear implant users compared to the traditional programming approach.
Read MoreThe research and support in practice by trained hearing health professionals provided the foundation to approve the indication be lowered to 9 months, along with the considerable developments in technology and evolving speech coding strategies in modern day cochlear implant devices.
Read MoreThe article estimates that Cochlear’s costs, including legal fees and interest, could exceed $750 million.
Read MoreAccording to the article, pediatric surgeries to correct hearing problems have already resumed in China, mostly in the areas outside Hubei province, where the coronavirus was most prevalent.
Read MoreMED-EL USA announced that Kenzi Cayton, 8, from Vancouver, Wash, was named the US winner of the...
Read MoreThere is a need to improve awareness and to better understand the impact and struggles of people who have unilateral hearing loss (UHL), the professionals who treat them, and those who work, live, and socialize with them. With better awareness comes better understanding, so health professionals can refer them rather than dismiss them. Moreover, better understanding can fuel motivation and allow the person with UHL to be more proactive about managing the condition while reducing anxiety.
Read MoreOtolaryngologist Yi-Chun Carol Liu, MD, performed the surgery on an 18-year old, and the device was successfully activated on November 13, 2018.
Read MoreWhat the hearing care field formerly knew as Sonitus Medical’s Soundbite system, a bone-conduction hearing device that resembled a dental bridge, has now re-emerged as Sonitus Technologies and a high-tech communications device called the ‘Molar Mic’ for military and rescue applications.
Read MoreMED-EL USA, Durham, NC, has been granted FDA de novo clearance for the BONEBRIDGE™ bone conduction hearing implant system for individuals 12 years and older who have been diagnosed with conductive hearing loss, mixed hearing loss, or single-sided deafness.
Read MoreThere has been great interest in using speech-evoked cortical auditory evoked potentials (CAEP) as an objective hearing aid validation measure, because CAEPs allow us to assess the audibility of speech sounds at the highest (cortical) levels. Here is a review by Sridhar Krishnamurti and Larry Wise, as well as results from a study they conducted that suggests there is clinical value of CAEPs for assessing cortical changes from amplification, as well as using this data in audiology services to demonstrate patient benefit.
Read MoreThe Baha SoundArc was designed to provide children with conductive hearing loss, mixed hearing loss, or single-sided sensorineural deafness (SSD) with the hearing performance and amplification they need to facilitate language development on par with their hearing peers.
Read MoreThe technique has the potential to improve a surgical procedure that often fails because of incorrectly sized prosthetic implants, researchers said.
Read MoreCan a fish with a malformed jaw tell us something about hearing loss in mice and humans? The answer is yes, according to a new publication in ‘Scientific Reports.’
Read More