On August 16th the Food and Drug Administration (FDA) released the final draft of revised regulatory regulations on over-the-counter (OTC) hearing aids, which will take effect in two months. Because most hearing aids are relatively expensive, the regulation is intended to promote innovation and increase competition by lowering the barrier to entry for new hearing aid manufacturers. Under the proposed regulations, hearing aids would be sold in more traditional brick-and-mortar retail stores or online (rather than in clinics or specialty retail stores) and would likely be cheaper than those currently sold, giving consumers more choices at lower prices. More importantly, the purchase of these hearing aids will no longer require a hearing test, diagnosis and prescription from a doctor or specialist. Anyone can purchase them directly from a store or online, which is very convenient.

“Hearing loss has a profound impact on the daily communication, social interactions and overall health and quality of life of millions of Americans,” said Acting FDA Commissioner Janet Woodcock, M.D. “The FDA’s proposed regulations represent an important step toward helping mild to moderate hearing loss adults better access to more affordable and innovative product options. The new regulatory category will provide greater control for the public to purchase hearing aids in stores nationwide or online without the need for professional hearing exams, fitting adjustments or prescriptions.

The FDA’s new regulations are designed not only to improve the accessibility of hearing aids, but also to encourage product innovation. In recent years, information technology innovation has continued, and new hearing aid products have emerged, with increasingly powerful functions, low safety risks, and good value for money. The OTCization of hearing aids will be conducive to the promotion of the application of scientific and technological innovations. And thanks to the establishment of the OTC Act, the OTC hearing aids produced by JINGHAO can be oriented to a larger group of consumers, which also brings more convenience and choice space to the majority of people with hearing impairment.

Founded in 2011, JINGHAO Medical focuses on the research, development, production and sales of hearing aids, and is committed to providing audible companionship for people with hearing problems. At the same time, JINGHAO Medical is the first hearing aid company in China that has its own algorithm and chip, and owns several invention patents and software copyrights related to hearing aids. Since its establishment in 2011, the company has obtained FDA, EU, CE certification, and ISO13485 medical device quality management system certificate, etc. It has obtained 128 patent authorizations and 8 copyrights, including 5 invention patents.

JINGHAO is committed to improving people’s hearing and reducing the inconvenience caused by hearing loss through excellent products. And we focus on providing stylish, cost-effective professional products to enhance customer experience through easier to reach, easier to operate and more intelligent products and services. And thanks to the establishment of the OTC act, to a certain extent, supplemental hearing headphones, as an affordable alternative to medical-grade hearing aids, can well meet the demands and budgets of people with mild to moderate hearing loss to enhance their hearing, and also enable more Americans to enjoy the health-care services brought by the law.

The ruling enacting the OTC act has increased the freedom to purchase hearing aids, which will stimulate the need for online purchases and self-administered fittings. Traditional purchasing methods require time to make appointments with audiologists and on-site meetings for fitting and testing of hearing aids. For convenience and time saving, people need to be able to order and adjust their own hearing aids online, and the market for OTC hearing devices with independent audiometry will explode in this period. JINGHAO’s OTC products are equipped with the APP smart hearing which can be operated and adjusted independently to adjust the volume, switch the mode and test the power, which can help users to wear and adjust the devices better. The company has also been committed to research and development of new OTC hearing devices, to bring people more comfortable and practical devices and technological protection, in order to help people live a better life through good hearing aids.

Link:JINGHAO is ready for the coming over-the-counter hearing aid market

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