Survey Details OTC Self-Fitting Hearing Aid Users’ Experiences, Perceptions
This survey provided insights into OTC hearing aid users’ experience, Eargo’s contribution to the landscape of hearing healthcare, and more
This survey provided insights into OTC hearing aid users’ experience, Eargo’s contribution to the landscape of hearing healthcare, and more
Over-the-counter hearing aids will touch the lives of many and bring the connection to tens of millions of un- and under-served Americans suffering from perceived mild-to-moderate hearing loss, who would otherwise have limited options for relief.
Knowles Corporation, a provider of advanced micro-acoustic microphones, speakers, audio solutions, high-performance capacitors, and RF products, announced the RAQ, a new medium-power balanced armature receiver developed for high-volume hearing health and TWS products.
The National Association of Attorneys General (NAAG) cautions that OTC hearing aid rules currently under review by the FDA may unintentionally hinder or repeal important consumer protection authorities, undermining states’ ability to ensure safe and affordable access to hearing aids. Currently, all 50 states have hearing professional licensing requirements and many have important protections for hearing aid consumers, including advertising restrictions, as well as mandatory warrantees and returns.
Read MoreThe Hearing Industries Association (HIA) announced that it has submitted comments in response to the proposed over-the-counter (OTC) hearing aid rules published by the Food and Drug Administration (FDA) on October 20, 2021.
Read MoreCochlear implants are already FDA approved for those with moderate-to-profound bilateral sensorineural hearing loss. With this approval, Cochlear can expand implantable treatment options for those with UHL/SSD to include cochlear implants, for the first time, according to its announcement.
Read MoreHearing loss has been linked to mutations in at least 100 different genes, but up to 16% of genetic hearing loss can be traced to just one gene, STRC, the second most common genetic cause. A first-of-its-kind gene therapy technique developed at Boston Children’s Hospital successfully replaced the mutated protein, stereocilin, in the inner ear and reversed severe hearing loss in mice — sometimes to normal levels of hearing.
Read MoreFennec Pharmaceuticals Inc, a company developing a drug to help prevent cisplatin-related hearing loss in children, announced that it expects the FDA to decline its marketing application for Pedmark, “Reuters” reported.
Read MoreNeuromod Devices Ltd, the medical device company which specializes in neuromodulation technologies, has announced the appointment of Teri Minard as Director, Government Sales of its recently established US entity, Neuromod USA Inc.
Read MoreStarkey President and CEO Brandon Sawalich has issued a statement regarding the recent proposed ruling by the Federal Food and Drug Administration (FDA) outlining a new category of hearing aids that can be sold over the counter (OTC).
Read MoreTo ensure patient safety, the proposed rule addresses maximum output limits and includes certain device performance and design requirements, such as distortion control limits, self-generated noise limits, latency limits, frequency bandwidth, as well as a requirement to limit the insertion depth of the device. The proposed rule also includes labeling requirements for OTC hearing aids. As hoped, the FDA also issued an updated draft guidance, “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs).”
Read MoreCochlear Limited (ASX: COH) announced that it has obtained Food and Drug Administration (FDA) approval and clearance in the last month for its Cochlear Remote Assist solution in the Nucleus and Baha Systems.
Read MoreA new, thumb-sized device from iotaMotion called iotaSoft intended to help place cochlear implants into patient’s ears, received De Novo clearance from the Food and Drug Administration (FDA), according to an article in “Fierce Biotech.”
Read MoreSummative Usability Validation has been completed, which helps demonstrate that users can “safely and correctly use the Intricon self-fitting technology,” and the clinical trial of the software can move forward.
Read MoreOTC hearing aids don’t have to be something you dread. You can use it as an opportunity to revolutionize your practice and make changes that work in both your and the consumers’ favor.
Read MoreStarkey announced that it welcomed US Senator Amy Klobuchar of Minnesota to its global corporate headquarters last week. During the visit, Senator Klobuchar toured Starkey’s technology center and manufacturing facilities.
Read MoreSensorion and Cochlear Limited (ASX:COH), announce the initiation of a pilot study of the first-in-class small molecule drug SENS-401 (Arazasetron) in patients scheduled for cochlear implantation.
Read MoreNeuromod Devices Ltd, the medical device company which specializes in neuromodulation technologies, has announced the appointment of Eric Timm as Chief Executive Officer of its recently established US entity, Neuromod USA Inc, effective from October 1, 2021.
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