When does an “affordable hearing device” become an “over-the-counter hearing aid?” When the FDA finally gives companies like ZVOX Audio the green light to market their high-function hearables as true hearing aids. But in the meantime, expect to see more products like the new ZVOX VoiceBud hit the market.
Priced at $299 and positioned as an affordable “personal hearing device,” the VoiceBud VB20 has features normally found in digital hearing aids costing $799 or more. Just don’t call it a “hearing aid.” At least, not yet.
Why? Because the FDA currently allows manufacturers to market products as “hearing aids” only after they have applied for and received Class I or II medical device certification. That leaves any number of personal sound amplifiers, which many consumers use as hearing aids, out in the cold.
Hearing Aids By Any Other Name
Congress implemented a solution to the problem last year with passage of the OTC Hearing Aid Act. The law tasks the FDA with creation of a new category of “over-the-counter” hearing aids. Among other things, OTC hearing aids won’t be subject to as stringent a set of regulations as premium custom-fitted hearing aids.
But the law also gives the FDA until the summer of 2020 to define the new market and how it will be regulated. Until then, manufacturers of hearables can’t market their devices as hearing aids. Instead they must describe them as “personal sound amplification products (PSAPs).” Manufacturers must market them only for listening situations where consumers with normal hearing may need help.
ZVOX has been careful to follow the rules. It says it designed the VB20 is “for people who have trouble understanding voices in some circumstances.” For instance, directional microphones help people with normal hearing understand speech better in noisy environments like cocktail parties. And who among us hasn’t strained at times to hear the TV a little more clearly?
But the product’s specs scream “hearing aid.” Among other things, the VoiceBud VB20 includes:
- Dual directional microphones
- Four-channel/12-band wide dynamic range control
- A Bluetooth smartphone app for volume and other controls
- Feedback cancellation
- Ambient noise reduction
- Automatic dampening of dangerously loud noises
OTC Hearing Aids Waiting In The Wings
ZVOX is a small company but well-positioned to enter the OTC hearing aid marketplace. Founded in 2004 by a team of executives with extensive experience in the high-end audio business, ZVOX introduced the first commercially successful TV sound bar.
Then in 2016, it introduced a TV speaker designed to improve dialogue clarity. Algorithims in its AccuVoice technology—similar to those found in high-end hearing-aid sound processing software—lift voices out of background sounds and bring them forward for easier comprehension.
The company also has extensive distribution for its consumer audio products online, in big-box outlets such as Best Buy, and in more than 200 high-end audio retailers in the U.S. and abroad. It understands how to deliver a sophisticated product to motivated users willing to pay $300. That price point is an emerging sweet spot for high-end hearables.
“For over 15 years, consumers have basically had two choices,” says ZVOX CEO Tom Hannaher. “They could buy a low-priced hearing amplifier or spend a lot of money on a sophisticated hearing device. With the VoiceBud VB20 they can now get advanced hearing technology at a reasonable price.”
With the VoiceBud hearable, ZVOX is set to roll all its technical and commercial experience into a new class of hearing aids. It can join other high-end hearables, such as IQ Buds, that are waiting in the wings for the FDA to green-light OTC hearing aids. When it does, ZVOX should have a running start in a hot, new market.
David Copithorne says
That’s a great question. I don’t know how long it will take to integrate bi-cross capability into more affordable hearing aids. I’m assuming bi-cross requires wireless ear-to-ear communication between both hearing aids, which requires more circuitry, which means more cost. But with chip costs continuing to come down, I won’t be surprised to see more wireless capabilities in more affordable hearing aids as time goes on. I’d love to hear from anyone else who’s close to these technologies and who might hazard a guess about how long they might come into view.
Liz says
All of these “reasonably priced” hearing aids leave out a large market share. Where are the “reasonably priced” cross or bi-cross hearing aids. I’m thrilled that some day hearing aids may be “affordable” but what I have so far will not be. Is anyone working on those products?
Thanks