FDA Grants De Novo Classification to TytoCare’s AI Otoscopy Tool
The AI-driven software analyzes otoscopy videos to detect eardrum bulging, establishing a new regulatory category for ENT diagnostic aids.
Tag: FDA
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PNQ Health Gets FDA Clearance for Tinnitus Treatment Platform
PNQ Health received FDA clearance for its Class II SaMD digital health platform, offering a telemedicine-based approach to treat tinnitus.
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Jinghao Medical’s Self-Fitting OTC Hearing Aid Gets FDA Approval
Jinghao Medical, a hearing aid manufacturer based in China, announced that its self-fitting OTC hearing aid has received FDA 510K approval.
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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Horizon Releases Data Related to Hearing-related Events with Tepezza
Horizon Therapeutics announced results from a new post-marketing safety analysis of hearing events associated with TEPEZZA for the treatment of Thyroid Eye Disease (TED).
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Sontro Hearing Aids Win BIG Innovation Award
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.
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Dr Robert Califf ‘Narrowly Confirmed’ By Senate to Lead FDA
Robert Califf received Senate confirmation as commissioner of the US Food and Drug Administration (FDA) today.
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Knowles Introduces New Balanced Armature Receiver for OTC Market
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.
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Healthcare Equality Network Requests Changes to Proposed OTC Hearing Aid Rule
The Healthcare Equality Network (HEN)—a group advocating for equal, quality access to healthcare for Black Americans—recently wrote a letter to the Food and Drug Administration (FDA) proposing changes to the OTC Hearing Aid Rule.
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CES 2022 and OTC Hearing Aids
Wireless earbuds and innovative audio solutions were one of the predominant themes of this year’s Consumer Electronics Show (CES) in Las Vegas. Here are HR Editor Karl Strom’s three takeaways from CES2022 regarding innovation and the upcoming OTC hearing aid category.
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GN Launches Jabra Enhance Plus Earbuds
GN announced availability of the “first-of-its-kind innovative Jabra Enhance Plus earbuds engineered for hearing enhancement” in the US on February 25.
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Eargo Supports Proposed Rule for OTC Hearing Aids
Eargo, Inc (Nasdaq: EAR), a medical device company on a mission to improve the quality of life of people with hearing loss, announced the submission of public comments to the Food and Drug Administration (FDA) concerning its proposed rule to create a new regulatory category of over the counter (OTC) hearing aids.
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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.
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HLAA Files Comments to FDA for OTC Hearing Aid Rule
The Hearing Loss Association of America (HLAA) announced that it filed comments to the Food and Drug Administration (FDA) on its proposed rule establishing Over-the-Counter (OTC) hearing aids. Once finalized by the FDA, consumers 18 and older with mild-to- moderate hearing loss will be able to purchase hearing aids at retail and online outlets.
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NAAG Urges FDA to Preserve State Regulation of OTC Hearing Aids
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.
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HIA Responds to Proposed FDA OTC Hearing Aid Rule
The 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.
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Cochlear Nucleus Receives FDA Approval for UHL/SSD
Cochlear 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.
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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.
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