Tag: FDA



Oticon Medical Announces FDA Clearance of Ponto 5 SuperPower

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.

FDA Issues Proposed OTC Hearing Aid Rules

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 As hoped, the FDA also issued an updated draft guidance, “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs).”

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Neuromod Appoints Eric Timm as US CEO

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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Neuromod Opens USA HQ

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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‘NBC News’ Article Discusses OTC Hearing Aids

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 Store Nord Launches Jabra Earbuds

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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