Tag: FDA

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Starkey Issues Statement On FDA Proposed OTC Ruling

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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Losartan May Help Patients with Vestibular Schwannomas

New research led by investigators at Massachusetts General Hospital (MGH) and Massachusetts Eye and Ear indicates that the blood pressure drug losartan may benefit patients with neurofibromatosis type 2 (NF2), a hereditary condition associated with vestibular schwannomas, or noncancerous tumors along the nerves in the brain that are involved with hearing and balance.

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A Comment on Biden’s Recent Executive Order Regarding Hearing Care

Recently, Good Morning America (ABC) aired a story about a recent announcement from the Biden administration regarding hearing aids. According to the story, the Biden administration has issued an executive order directed to the Department of Health and Human Services to do two things. First, to issue plans to “combat price gouging” regarding hearing aid costs within 45 days and second, to take action within 120 days to propose getting hearing aids available over the counter.

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Fennec Resubmits FDA Application for Pedmark

Fennec Pharmaceuticals Inc announced that the FDA has accepted for filing the resubmission of its New Drug Application (NDA) for PEDMARK for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to < 18 years of age with localized, non-metastatic, solid tumors.

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Comparing Population Coverage between Hearing Aids Using Presets vs Bose CustomTune

The self-fitting Bose SoundControl™ hearing aid is the first of its kind to gain FDA clearance. In the self-fitting process, the Bose Hear app uses the Bose CustomTune™ interface for mapping to a wide range of target gain profiles, derived from a hearing loss database. This article compares the population coverage—or the percentage of people who would be able to find a frequency gain profile similar to a NAL-NL2 prescription fit—of SoundControl to other self-fitting amplification devices which typically feature only 1 to 4 preset gain profiles.

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Frequency Therapeutics Supports HLAA Meeting on SNHL

Frequency Therapeutics, Inc, (Nasdaq: FREQ) shared a statement from David L. Lucchino, Frequency’s Chief Executive Officer, in support of the Hearing Loss Association of America (HLAA) and its efforts to advance the voice of the patient in leading “the first-ever Externally-Led Patient-Focused Drug Development (EL-PFDD) meeting on sensorineural hearing loss (SNHL).”

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Study Shows Hearing Improvement with Esteem Implant

Envoy Medical Corporation, a hearing health company focused on providing innovative technologies across the hearing loss spectrum, announced an independent study that was published online in ‘The Journal of Laryngology & Otology.’ The study found that the fully implanted Esteem osseointegrated active middle ear implant (AMEI) showed “statistically significant improvements in post-operative hearing results,” according to Envoy.

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