Jabra’s New Hearing Aid: What Does the Future Hold?

On January 19th, the U.S. Food and Drug Administration (FDA) cleared the way for Jabra to sell its new Enhance Plus™ earbud as a self-fitting hearing aid. The device was cleared by the FDA on the basis of being “substantially equivalent” to the Bose SoundControl™ hearing aid, which was previously the only self-fitting hearing aid registered with the FDA.

Enhance Plus provides hearing enhancement for users with milder forms of hearing loss. The FDA reports that the device incorporates “a reliable self-fitting method” that provides “functional performance that is not inferior to that provided by a professional hearing aid fitting”.

Jabra Enhance Plus

Jabra Enhance Plus

The device will be available to purchase on February 25th via licensed hearing care providers. Jabra is owned by GN, a leader in the global hearing aid industry—GN manufactures ReSound, Beltone, and Lively hearing aids, among others.

Not an over-the-counter device

The FDA clearance comes as the agency collects comments on a proposed rule to make hearing aids available as over-the-counter (OTC) medical devices.

Gitte Aabo, CEO of GN

Gitte Aabo, CEO of GN

“Jabra Enhance Plus has been submitted and approved under the self-fit hearing aid category and does not come under the OTC category…this category doesn’t exist today,” Gitte Aabo, CEO of GN, tells HearingTracker.

The proposed OTC rule outlines two distinct new hearing aid classes—OTC hearing aids and self-fitting OTC hearing aids. Whether Jabra Enhance Plus (and other self-fitting hearing aids) will be classified as a self-fitting OTC in the future is not clear.

GN did not say if the product could one day be sold without a prescription, but FDA filings state that the Enhance Plus is “intended for direct-to-consumer sale without the assistance of a hearing care professional”. And The New York Times reported that “Jabra will initially sell the Enhance Plus set through audiologists […] with the plan to offer it at retail via the web once the hearing-aid rules have passed.”

“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,” René Svendsen-Tune, CEO at Jabra, said in a statement.

This sentiment was echoed by Aabo in a recent GN earnings call when she said “once the OTC regulation comes into force we certainly also expect Jabra Enhance Plus to fit under that regulation.”

Hearing aid earbuds

Jabra’s earbuds fuse hearing aid technology and earbud design—they go in the ear not above it as traditional hearing aids do.

According to Jabra, the product provides hearing enhancement for clearer conversations, listening to music, and taking calls. The earbuds combine the convenience and design of true wireless earbuds with advanced hearing technology and are geared toward people with mild-to-moderate hearing loss. Wireless streaming and hands-free calling will be available to users with an iPhone running iOS 14 or later.

“They are the most consumerized hearing enhancement earbuds on the market, and a pioneer in self-personalization,” Aabo said. “With this launch, we are creating a new standard in miniaturized technology, harnessing hearing enhancement with the highly valued consumer electronics benefits of true wireless earbuds, all without compromising on the battery life, delivering twice as much as most earbuds on the market today.”

“This is a ground-breaking innovation,” she said.

The company said they are the smallest of its kind in the market. They are 40 percent smaller than leading true wireless earbuds on the market, the company said in a statement.

The hearing aid earbuds can last 10 hours on a single charge, and are both water and dust resistant, with an IP52 ingress protection rating. There are three listening modes. Users will need to download the Jabra Enhance app for iPhone to set up and fully utilize the earbuds.

Jabra Enhance App

The Jabra Enhance App

The hearing aid earbuds will be sold at participating hearing care providers for $799 MSRP (Manufacturer’s Suggested Retail Price) per set. The final retail price for consumers will depend on whether clinical services, such as diagnostic hearing tests (required by law in some states), are rendered at the point of sale.

“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,” Aabo said in a statement.

Anticipating over-the-counter FDA approval

On July 9, U.S. President Joe Biden’s signed an executive order—the Executive Order on Promoting Competition in the American Economy—that requested the U.S. Department of Health and Human Services to “promote the wide availability of low-cost hearing aids” and “publish for notice and comment a proposed rule on over-the-counter hearing-aids” by early November.

That proposed rule came in In October 2021, when the FDA released a draft of a regulation that would add an Over-The-Counter (OTC) Hearing Aid category. The new rule would enable the direct sale of OTC hearing aids to adults, without the need for a hearing exam. The proposed rule is part of the already-approved FDA Reauthorization Act of 2017.

And just this Wednesday, a coalition of 11 U.S. senators, including a full bipartisan spectrum (from Bernie Sanders to Lindsey Graham), signed a letter to Janet Woodcock, the Acting Commissioner of the FDA, urging the FDA to “finalize the rule without delay”.

Under the proposed rule, hearing aids for severe hearing loss or users younger than age 18 would be offered only by prescription.

Disrupting the industry

There’s been a bit of a back-and-forth exchange in the comments of the proposed rule regarding the maximum output (volume) limit, which aims to prevent injuries from the over-amplification of sound. The proposed rule includes specifications on performance and design requirements including insertion depth, distortion control limits, self-generated noise limits, latency limits, allowable frequency ranges, and how uniformly the OTC hearing aid amplifies different frequencies over its bandwidth. The proposed rule also includes labeling requirements for OTC hearing aids.

The concept of making hearing aids available over the counter has been met with controversy. Supporters say the move will give more people access to affordable hearing treatments, while opponents) have expressed concern about people getting accurate, appropriate treatment.

Another point of contention has been the idea of “preemption”. Under the proposed rule, the FDA’s regulations would preempt any state or local rules that would “restrict or interfere with commercial activity involving OTC hearing aids”. A bipartisan coalition of U.S. attorneys general urged the FDA to “preserve states’ authority to enforce their consumer protection laws in connection to the sale” of OTC hearing aids.

Final approval on OTC hearing aids is expected sometime later this year.

“The commenting period is over, which means that the FDA is now reviewing and answering comments while finalizing the regulations,” Aabo said.