Tag: FDA

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NCL Supports “Safe OTC Hearing Aid Standards”

Mild-to-moderate hearing loss is a difficult reality that millions of Americans struggle with, which is why the availability of over-the-counter (OTC) hearing aids is exciting for those who are impacted by hearing loss. While making OTC hearing aids more accessible is a promising step for consumers, we at NCL would be remiss if we didn’t underscore our concerns around the Food and Drug Administration’s (FDA) proposed OTC hearing regulations as they currently exist.

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Gene Therapy for Hearing Loss Reversal

Hearing 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.

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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Neuromod Appoints Susan Whichard to Board

Whichard has more than 30 years’ experience in the hearing industry, having worked as both a business executive and a practicing healthcare professional, as a clinical audiologist. Her appointment comes as Neuromod plans continued expansion of the availability of Lenire, its tinnitus treatment device across Europe and in the US, pending FDA approval, according to the company’s announcement.

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Akouos’ AK-OTOF Receives Orphan Drug Designation

Akouos, Inc announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) issued a positive opinion on the company’s application for orphan drug designation for AK-OTOF, a gene therapy intended for the treatment of otoferlin gene-mediated hearing loss. The positive opinion was subsequently adopted by the European Commission.

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