PSAPs - report from Peter Sydserff (6.3.20)

PSAPs

“The number of ‘hearing amplifier’ type devices is on the rise. BSHAA Council member Peter Sydserff puts one of the latest to the test – and is worried by the results. Is it now time for these devices to be properly regulated?”
“Confused.com

The world of product in our sector is confused. We have devices that aspire to be hearing aids and hearing aids that are now designed to look like hearables, wearables or whatever else you want to call them. That’s OK though, isn’t it? Innovation and positive disruption is how we all learn what ultimately works for an increasingly diverse group of customers. We waited a long time for the baby boomers to get interested in what we have to offer because we are told that there are literally millions of them. But what we must be wary of, and in some cases wary of on their behalf, are the marketeers who would prey on those with hearing loss who don’t know how to go about seeking help or simply don’t yet value what a Hearing Aid Audiologist can do for them. In this article we will look at some of the devices available today at the ‘value’ end of the market.

We’ve been here before…

This is not the first time I have written on the subject of devices that appear to be hearing aids and yet, still, aren’t. In the past the words have been about ‘hearables’ or ‘headphones with benefits’ but this article will look at a product group that could actually cause harm, rather than help.

This is a good point to repeat that your Society will always support any innovation that increases access to better hearing for the general public. But I caveat that by saying that BSHAA will also speak up if it sees examples of a poor patient experience.

The worst of these products have been exposed publicly by the BBC’s Fake Britain series (series 9, episode 6) broadcast on 2 December 2019. In the episode, BSHAA member Nick Clive gives his perspective on so-called PSAPs (Personal Sound Amplification Products) and rightly paints a dim picture of products that are capable of over-amplification and exceeding sound levels that we know can damage hearing, rather than help it.

BSHAA has history in this area.

In 2015, we contacted Lidl after receiving reports that the budget supermarket giant was advertising a ‘Sanitas’ hearing aid for sale that was capable of delivering high levels of amplification. It was explained to Lidl that there is regulation around who can sell any product called a ‘hearing aid’. Furthermore, it was confirmed that no form of assessment of the patient was carried out prior to or after the sale of said ‘hearing aid’. We cannot claim any victories here, but the product was withdrawn from sale later in the year.

How did we get here again?

Early in the year a patient reported to an audiologist in a BSHAA member’s clinic that they had bought a hearing aid from Argos. It’s worth clarifying that this was not a complaint – in fact, the patient believed that it was worth every penny and had actually helped them decide that they should be looking for a ‘proper’ hearing aid and some professional care! But this naturally sparked our interest as to whether there was a new market entrant…

A quick look on the Argos website reveals that there are actually three ‘hearing amplifiers’ for sale today. One is the Beurer HA20 at £19.99.

In fact, our curiosity got the better of us and we went and bought one. This is what we found…

Packaging – of reasonable quality given the price point. Many languages delivering the same message. Already beginning to look suspiciously like the Sanitas product sold by Lidl in 2015.

Instructions – does advise purchasers to seek professional advice before use, but it’s already been purchased at that point. Use with anyone under the age of three is not recommended, but by implication, anyone over three years old is fine!

Batteries – Argos website says alkaline, but the product is actually supplied with size 13 zinc air batteries.

Design – big, unsightly and a poor advert for the brand of hearing aids.

Output – on a test box on maximum, output was measured at 125dB. Considerable low frequency gain rolling off in the high frequencies before disappearing at 4KHz. The output of the product was measured on full volume and it didn’t quite achieve the claimed 128dB, but it was close…

Just to see how close the frequency response would get to the desired response to a mild/moderate sensorineural hearing loss, we then entered an audiogram that would be typical of someone who wants to do ‘something’ about their hearing (a typical mild-moderate sloping loss).

We then set the product to half volume and measured its output compared to target. A woeful miss with under-amplification in the important high frequencies and over-amplification in the low frequencies. A trained eye can predict what the patient experience of trying to hear through this device might be? It’s also worth observing that the Argos website claims a frequency response between 200Hz and 5000Hz, the output graph shows little or no amplification after 4000Hz.

In conclusion, we have established that the device is of poor quality and is capable of producing dangerous sound levels if turned up to full volume. The other observation is that the packaging and overall design closely resembles that of the ‘Sanitas’ hearing aid (Aldi’s description, not ours) sold by Aldi in the UK but withdrawn a few years ago.

Time for regulation?

In 2015, the European Association of Hearing Aid Professionals researched and produced a report on PSAPs via their European Committee for Audiology and Technology. The report into each product (the Lidl ‘Sanitas’ product is included) is detailed and makes the interesting observation that the sale of these devices is not regulated, but that the sale of far safer devices – hearing aids – is. Furthermore, these PSAP products should at least be regulated in a similar way to personal music players. Directive 2001/95/EC recommends maximum exposure time to loud sounds played through these devices, and all of the products that were researched exceed those recommendations at full volume.

At the time of going to print, we have contacted Argos with our findings and await their reply.

It’s not just Argos…

 

Of course, we have seen PSAPs for sale for years in off-the-page adverts and more recently online with well-known retailers like Amazon and eBay. But we have yet to see evidence of anyone coming to any harm as a result of them. That said, the promotion of these products does irritate and not because we believe their sale is intruding on any commercial opportunity for members. Again, although we can’t evidence it, we intuitively know that experiences with these products in the main will be negative ones, and this fact could put patients off using amplification for longer, or indeed forever. Finally, and by no means least, what expectation for hearing aids is created in the minds of anyone who observes someone actually using one of these things?

Worth noting at this point that the Society continues to monitor the sale of ‘real’ hearing aids online at eBay. As it is not illegal to do this, and eBay do caveat with appropriate warnings, then this remains something of a watching brief.”

 

Peter Sydserff, former President