In the latest round of the debate over whether the marketing of personal sound amplification products (PSAPs) is designed to confuse PSAPs with hearing aids, the Food and Drug Administration (FDA) has issued a new draft guidance on the two technologies.
“They have basically clarified the 2009 guidance document,” said Andy Bopp, executive director of the Hearing Industries Association (HIA). “The previous document said that PSAPs should not be sold to treat hearing loss or sold as hearing aids.
“Given the lack of specificity, PSAP marketers have essentially avoided the word ‘hearing aid’ and instead made claims to treat the conditions of hearing loss. For example, some PSAPs are sold to help people hear better in a movie theater.
“Anyone who has been to a movie theater lately knows that the volume is generally pumped up to maximum levels. If you cannot hear the dialogue in such a situation, you have hearing loss. For a marketer to claim otherwise is to seek out loopholes in the 2009 guidance document.”
The new draft guidance, issued Nov. 7, 2013, was subject to a 90-day comment period and had not yet been finalized. Compared with the older guidance, it contains more specific language and examples of suitable and unsuitable claims for personal sound amplification products, which are classified as wearable electronic products and are not subject to FDA review.
For example, the 2009 document listed situations when PSAPs are appropriate—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, such as distant conversations or performances.
It stated that PSAPs are “not intended to compensate for impaired hearing.” However, the document avoided going into any detail about situations for which PSAPs could not make claims without straying into the forbidden territory of hearing aids, which are subject to regulation as medical devices.
The new guidance gives examples of listening situations that are indicative of hearing loss: difficulty listening to another person nearby, difficulty understanding conversations in crowded rooms, difficulty understanding movie dialogue in a theater, difficulty listening to lectures in an otherwise quiet room, difficulty hearing the phone or doorbell ring, or difficulty listening in situations where environmental noise might interfere with speech intelligibility.
“Products making these or similar claims should not be considered PSAPs,” the document said.
It also spells out labeling claims and language “that would establish an intended use as a medical device”:
* 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.
* Wording to suggest that the product is an alternative to a hearing aid.
RECOMMENDED, BUT NOT REQUIRED
A 2010 study from the Better Hearing Institute (BHI) found that approximately 1.5 million people in the United States use a direct-mail hearing aid or PSAP to compensate for hearing loss—a figure that has almost certainly grown significantly in the four years since the study was conducted.
“As technology advances, there has been a great increase in the number of PSAPs marketed and a great increase in the number of claims made about them,” Mr. Bopp said.
PSAP descriptions often include a list of questions for prospective users, such as, “Do you find it difficult to understand conversations in noisy situations?” “Do you often ask people to repeat themselves?” “Do you have trouble hearing in a restaurant?”
Some even make an explicit link between their product and hearing loss: “Studies have shown that most persons experience some high-frequency hearing loss, and we've elected to produce a discrete, ready-to-use ‘amplifier’ and sell it direct to the consumer at a fraction of what hearing aids cost.”
Mr. Bopp noted the Food and Drug Administration's perspective on medical attention for hearing loss.
“FDA urges people to see a doctor to determine whether their hearing loss is caused by an easily treatable condition, such as a wax buildup, or a more serious condition that requires medical attention,” he said.
He linked this outlook to the agency's position on over-the-counter (OTC) hearing aids.
“FDA has rejected the concept of over-the-counter hearing aid sales, and the sale of PSAPs to address hearing loss constitutes OTC hearing aid sales through the proverbial backdoor.”
Despite the greater specificity of the FDA's new draft guidance on hearing aids and PSAPs, one big gap remains. Namely, the guidance document is just that—guidance. It represents the agency's current thinking on the matter but is not legally binding or enforceable.
“Without direct regulation from the FDA, I don't see things changing on the PSAP side,” said Patricia Gaffney, AuD, associate professor of audiology at Nova Southeastern University in Fort Lauderdale, FL, in an interview.
“PSAPs are still going to exist, and they're still going to market them the way they do. If they start pushing further over the hearing aid line, then the FDA will have to step in, but I don't think they're going to do that. They're going to continue to dance around that line.”
HERE TO STAY
Given that PSAPs seem to be here to stay, hearing healthcare professionals have raised a key question: “Instead of wishing [PSAPs] away, what if we were to embrace them?” as Dr. Gaffney asked during her presentation on PSAPs at last year's American Academy of Audiology annual meeting, AudiologyNOW! 2013, held in Anaheim, CA, in April.
With the help of a trained professional, a PSAP purchase might be a patient's first step toward getting an actual hearing aid, Dr. Gaffney said in the interview.
“I've had people come in to see me after buying a PSAP, and either it was really bad and didn't help at all, or it helped them enough to let them know they need more help.
“If someone has mild hearing loss and is wishy-washy about getting a real hearing aid, and then they get a PSAP and it benefits them a little but has limitations, they may be more likely to pursue real hearing aids.”
In addition to those who aren't ready for a hearing aid, patients who can't afford a hearing aid, have simple listening needs, have no to very minimal hearing loss, are going to use the device for a short period of time or a limited number of hours a day, or have a low perceived handicap might be a potential PSAP user, Dr. Gaffney said at AudiologyNOW! 2013.
Mr. Bopp worries that the sale of PSAPs by audiologists represents a slippery slope.
“An audiologist who conducts a hearing test, identifies a hearing loss, and then sells a PSAP is selling a product that is not approved by FDA to treat hearing loss,” he said.
“Once you do a hearing check and determine the person has hearing loss, you would have to be very cautious about what types of claims you would make.”
THE EXCEPTION, NOT THE RULE
Ellen Finkelstein, AuD, chief audiologist at East Side Audiology in New York, initially wanted nothing to do with PSAPs, but she said some courses have modified her views.
“There are people who may benefit from PSAPs who will not benefit from hearing aids or choose not to use them. I would rather be the person fitting a PSAP than having it done incorrectly.
“That means instructing a person how to use it properly, cautioning the user about things like not making it too loud, and making clear its limitations.”
Dr. Finkelstein does not often provide PSAPs, she said, agreeing with Mr. Bopp that audiologists’ regular provision of the devices would blur the line between those products and hearing aids. But she has made exceptions in specific cases, such as for people who cannot tolerate a hearing aid in their ear.
“For example, I saw one patient who had very, very mild loss of hearing and had seen four other audiologists, unsuccessfully trying one hearing aid after another,” Dr. Finkelstein said.
“She came up to me at a lecture and asked if I'd work with her. I got her a PSAP, and I counseled her and showed her how to use it. It's helping make her life a little bit easier.
“I will sell a PSAP to patients if they are insistent that they want it, and I will provide them with proper fitting and instruction on its use, making it clear that it does not replace a hearing aid.”
Patients need to have realistic expectations when it comes to PSAPs, Dr. Gaffney said at AudiologyNOW! 2013.
Typically, these products are not programmed to the patient's hearing loss, will not help in all situations, and will have feedback issues. Most don't have noise cancelers or directional microphones, a specific phone program, or dedicated accessories.
The PSAP has become like a bogeyman for audiologists, Dr. Finkelstein said.
“I believe that we cannot, as a profession, ignore the existence of PSAPs, even if we know that they are not the best solutions for managing hearing issues. We have to figure out a way to work with these and not run away from them.”
Provision of PSAPs by audiologists is likely to remain rare, Dr. Gaffney said in the interview.
“I haven't really heard of anybody making it a practice of selling them in their office. It does blur the line, and I think that's another reason why audiologists haven't gone that route.
“If they do it, they need to provide clear information as far as what that device is meant to do versus what a hearing aid is meant to do.”
The financial model is also a challenge, she noted.
“Even just to sell a PSAP, you'll have to build in some amount of your time, or an audiologist's assistant's time, to teach the patient how to use it and take care of it. So could audiologists compete with just buying the product online?”
She agreed, though, that there are certain patients who might be happier with a PSAP than a hearing aid.
“I had a patient who was a faculty member here who had borderline normal hearing with very, very mild hearing loss,” Dr. Gaffney said.
“Her biggest complaint was not being able to hear people from the back of the room. We tried traditional hearing aids with her, and she didn't get a lot of benefit and ended up returning them.
“Thinking about it now, for someone like that with such mild hearing loss that is mostly a situational problem, a PSAP might help.”
LINK TO MORE INFORMATION
* Read the FDA 2013 draft guidance on PSAPs: http://bit.ly/FDA-2013.
* Review the FDA 2009 guidance on PSAPs: http://bit.ly/FDA-2009.
* Access the letter of concern about PSAPs from hearing healthcare organizations: http://bit.ly/PSAPLetter.
* Learn about the American Academy of Audiology resolution on PSAPs: http://bit.ly/AAA-PSAP.
* Get details on the International Hearing Society Position Statement on Personal Sound Amplifiers: http://bit.ly/IHS-PSAP.
* Read the HJ story on Internet hearing aid sales: http://bit.ly/HJ-Internet.
* Review the MarkeTrak VIII survey on PSAP use: http://bit.ly/MarkeTrak.