FDA Clears Jabra Enhance Plus as Self-Fitting Hearing Aid Ahead of OTC Regulations

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HHTM
February 8, 2022

COPENHAGEN, DENMARK – GN today announces the availability of the first-of-its-kind innovative Jabra Enhance™ Plus earbuds engineered for hearing enhancement in the US on February 25th

Jabra Enhance Plus “combines the convenience and design of true wireless earbuds with  advanced hearing technology to address the needs of millions of Americans with mild-to moderate hearing loss, helping them take the first steps on their hearing health journey”. 

Jabra Enhance Plus comes in a miniaturized earbud design, 40% smaller than leading small true wireless earbuds in the market2.

Jabra enhance plus charger

The new Jabra Enhance Plus will be available through licensed hearing professionals, with MSRP of $799 

The earbuds are designed with “cutting-edge  personalization technology, enabling individualized situational hearing enhancement during real-life conversations, and includes high-quality calls and music quality. They will provide hearing help for users in a comfortable design that will be the smallest of its kind in the market. The stylish design combines organic and modern lines, creating a desirable look both in and out of the ear”. It offers 10 hours of battery life on a single charge and is said to be water and dust resistant. The simple setup is conducted through the Jabra Enhance app. 

According to the company, the Jabra Enhance Plus has been developed according to the highest standards of quality and has been 510(k)-cleared with the FDA under the self-fit hearing aid regulation (Bose is the only company currently authorized in this category).

The new  earbuds3 will be available from February 25th this year in select Hearing Care clinics across the US, with a recommended retail price of $799 USD1.  

 

Anticipating the OTC Hearing Aid Regulation 

 

jabra enhance plus hearableToday, more than 50 million American adults live with some level of untreated hearing loss. This makes hearing loss one of the most prevalent and largest untreated health conditions in  the US. In October 2021, the FDA released a draft regulation to introduce a new Over-The Counter (OTC) Hearing Aid category. The bill is designed to allow greater access and more affordable hearing treatment options.  

“GN welcomes the intention of increasing awareness and treatment of hearing loss to improving people’s quality of life through the power of sound. With Jabra Enhance Plus,  more people will have a solution that has been specifically tailored to their needs and  lifestyle”

–Gitte Aabo, CEO of GN Hearing

“When the new OTC regulation comes into effect, we look forward to be there to help people  with solutions that provide better situational hearing as well as music and calls in modern  and stylish designs”, says René Svendsen-Tune, CEO at Jabra. 

The company indicates that it hopes to launch Jabra Enhance Plus in further markets internationally, as local regulations develop. 

Interested to learn more about the Jabra Enhance Plus? Don’t miss the interview with GN Hearing CEO, Gitte Aabo:

Learn more about the new Jabra Enhance Plus at visit the company’s website here. Available in select Hearing Care Clinics across the US from February 25th.  

  1. Professional services (incl. hearing tests) to assess candidacy required by respective state law.  Fees for such services vary by location and Hearing Care Professional. These are additional to the  recommended MSRP (Manufacturer’s Suggested Retail Price) 
  2. 40% smaller compared to Jabra Elite 7 Pro, amongst the smallest true wireless earbuds
  3. Only compatible with iPhone devices 

 

Source: GN

  1. I found this very interesting! Since the pandemic began, I’ve been wearing Bose Hearphones, and I love them. But if and when they cease to function (never, I hope), I might be interested in something like this Jabra product. I’m very pleased to see this kind of thing come along, and am anxious to see if it can reach the people who need it (especially at this affordable price range), and dislodge some of the entrenched, and needlessly expensive, traditional hearing-air market.

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