The U.S. Food and Drug Administration (FDA) is continuing to split hairs as it attempts to draw a clear distinction between hearing aids, which are Class I medical devices subject to government regulatory oversight, and personal sound amplification products (PSAPs), which are not. While its recent draft guidance document updating its 2009 Regulatory Requirements has more emphatic wording, it continues to draw the same inadequate distinction between the two types of devices. Unfortunately, the new guidance as currently drafted seems destined only to exacerbate the simmering conflict between hearing aid makers and PSAP marketers.
In 2009, the FDA said the difference was in the intended use of each product. It said because hearing aid makers market their products as a way to alleviate a medical problem — hearing loss — they should be subject to government regulations. But as long as PSAP makers only market their products for recreational uses such as “hunting (listening for prey), bird watching, listening to lectures with a distant speaker, and listening to soft sounds that would be difficult for normal hearing individuals to hear,” they are not selling medical devices and need not be regulated.
In other words, if the PSAP is not sold as a way to correct hearing loss, it’s not a medical device subject to regulatory oversight.
But PSAPs use the same technologies as hearing aids, look like hearing aids, and amplify environmental sound like hearing aids. And the new FDA document does little to resolve the question that’s bothering everyone: “If it quacks and has a bill, wings, white feathers and webbed feet, isn’t it a duck?”
Unfortunately, the new FDA document draws exactly the same distinction based on intended use that it drew in 2009 without shedding much new light on the situation. Sure, it tries to strengthen the prohibition of PSAP makers marketing their products as hearings aids by giving explicit examples of verboten PSAP labeling and promotion claims. For instance, “a description of the types and severity of hearing loss; a description of listening situations that are typically associated with and indicative of hearing loss; and wording to suggest that the product is an alternative to a hearing aid” are forbidden. That’s all well and good, and it supports the hearing aid makers who have already been very aggressive about calling out PSAP makers who advertise their products as inexpensive be-all-end-all solutions to hearing loss. But it doesn’t stop or discourage PSAP buyers from using them to correct their hearing loss anyway.
Worse, the FDA draft guidance document muddles what in my mind is a more important distinction between hearing aids and PSAPs — the fact that hearing aids are programmed to compensate for the individual patient’s hearing loss based on a hearing test administered by a licensed professional, whereas a PSAP is not tuned or programmed to the individual’s tested hearing profile. The FDA mentions the fact that hearing aids require a licensed professional to do the programming but then gets a little lost in a description of the new integrated wireless technologies that stream audio from the phone, TV, stereo and tabletop microphones directly to hearing aids:
Hearing aids may be coupled acoustically or wirelessly to external electronic products such as televisions, MP3 players, and telephones. A hearing health professional (such as an audiologist or a hearing aid dispenser) is usually required to program and optimize the performance of hearing aids with these more complex features.
It’s a little ridiculous to say you need a hearing health professional to program your wireless connection from your electronic devices to your hearing aids. When you bought a Bluetooth earpiece from Radio Shack, did you need to go to an audiologist for help pairing it with your mobile phone? When I bought my TV streamer for my Phonak hearing aids and asked my audiologist how to use it, he said “Plug the transmitter into the TV and hang the streamer around your neck. And don’t forget to turn them on.” That was it. And they work GREAT. No professional intervention required.
That’s because the compensation for my hearing loss isn’t done by the TV streamer, it’s still done in the hearing aids. When I need the hearing aids adjusted, I go straight to the audiologist. When I attach a peripheral that merely streams audio into my hearing aids, I do it myself.
In my mind, the FDA should ignore the wireless devices to the same degree it ignores Bluetooth earpieces or iPod/iPhone earbuds. But unfortunately, some might take the draft guidance to imply that the new wireless peripherals transmitting to in-ear hearing devices should be regulated like the hearing aids, which would make it harder for an entirely new class of wireless consumer devices — such as a PSAP that can receive wireless transmission from a TV streamer — to get to market.
So I think the FDA should rework its draft substantially:
- The distinction based on intended use is fine and necessary, but nowhere near sufficient.
- The language on the role of the licensed professional should be emphasized in more detailed and appropriate ways. The hearing professional is absolutely essential in testing my hearing, providing an accurate hearing profile, and programming my hearing aids so that they actually help correct my hearing loss in the most accurate (and safe) way possible. To protect consumers, the FDA should emphasize that licensed professionals are the ones who deliver amplification that will correct deficiencies in hearing loss without over-amplification that can damage hearing.
- I also think the FDA should consider coming up with guidance discouraging dangerous volume thresholds in PSAPs and look at other parameters that can be measured, monitored and if necessary regulated to protect consumers from the possibility of damaging their hearing with a device bought over the counter. The European Union has already taken a hard look at MP3 players and encouraged manufacturers to set volume controls.
Those are just a few thoughts. It would be nice to see the emergence of responsible PSAP makers continue alongside the ongoing success of the regulated hearing aid makers. I truly believe there’s plenty of room for all players in the market for solutions that help people hear better in challenging listening environments.
With luck the FDA can come up with guidance that encourages more innovation that will enable industry to reach more consumers — including both those with hearing loss and those with normal hearing — who need help in all kinds of challenging listening situations. But right now PSAP makers and hearing aid makers are too often squared off against each other.
The FDA is accepting comments on the draft guidelines until February 2014. If you have any constructive thoughts, go to the FDA comments page and weigh in!