Neuromod Devices' Lenire, a bimodal neuromodulation device, has received De Novo approval from the FDA to treat tinnitus. According to the company, Lenire is the first of its kind to receive FDA approval.
The Sontro Hearing Aids (Model AI) are wireless, self-programming hearing aids that have been developed to amplify sound for individuals 18 years or older with perceived mild-to-moderate hearing impairment.
Introducing ‘full SuperPower strength in the smallest SuperPower device ever available, the Ponto 5 SuperPower also delivers significant advancements in sound processor technology – including a patented feature to prevent audible feedback – along with a sleek cosmetic design,” according to the company.
Neuromod 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.
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Starkey 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).
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To 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 As hoped, the FDA also issued an updated draft guidance, “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs).”
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Cochlear 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.
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A 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.”
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Summative 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.
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OTC 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.
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Starkey 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.
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Sensorion 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.
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Neuromod 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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‘New York Times’ Personal Health writer Jane Brody, she discusses how new legislation related to coverage of hearing care coupled with increasingly innovative hearing aid design, may compel greater hearing device adoption among people with untreated hearing loss.
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The 2021 Edition of the Map is the latest in a longstanding series of diagrams that illuminates the hidden connections between hearing aid manufacturers and their subsidiaries.
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Neuromod Devices Ltd, the Irish medical device company specializing in the treatment of tinnitus, has announced the establishment of Neuromod USA Inc, headquartered in Oak Brook, Ill. Three executives with significant experience in the hearing health industry have been appointed to the Neuromod USA leadership team as the organization prepares to enter the US market with its medical device for tinnitus treatment, pending approval from the Food and Drug Administration (FDA).
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A recent article appearing on the “NBC News” website by Phil Galewitz with “Kaiser Health News,” discusses the expansion of over-the-counter hearing devices currently on the market for people with mild-to-moderate hearing loss, in the absence of FDA regulations governing the 2017 “Over-the-Counter Hearing Aid Law.”
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GN announced the extension of its Jabra Enhance line of hearing enhancement solutions designed to “help users hear more from life.” GN “brings together the convenience of true wireless earbuds with advanced hearing technology to alleviate unaddressed user needs and enable millions of people to take a first step on their hearing health journey,” according to the company’s announcement.
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