Medical hearables for hearing loss

Hearing loss prevalence

There are good reasons for wanting to alleviate middle-age hearing loss (HL):

    • People with untreated HL are twice as likely to feel left behind in job and salary prospects[1a].
    • People with untreated HL are 2.5 times more likely to suffer major depression disorders[1b].
    • Middle-age HL is a key risk factor that contributes 9% of dementia[2].
    • Untreated HL costs the UK £25.5 billion (US$32 billion) each year[3].
    • Untreated HL costs the world community at least US$750 billion each year[4].

Yet, most people with HL do not get hearing help. Here is why.

Today’s market model

466 million people worldwide live with a disabling HL[4]. About the same number again live with a milder hearing impairment, which nonetheless reduces brain stimuli and affects quality of life potential. Global hearing aid sales were just 16 million units in 2018. When the average hearing aid lasts 4 years and 80% of users wear 2 aids and 8% own an alternate pair[1c], this equates to a mere 8% penetration of disabling HL and about 4% penetration of all people at risk of comorbid conditions. In the UK the penetration of disabling HL was a world-leading 48% in 2018[1d], which is more comfortable but still very poor. In conclusion, the established market model does simply not reach people in need and at risk. The under-service costs society and individual citizens dearly.

I happen to be one of those middle-aged people with a HL and I can relate to a number of reasons for penetration being so unreasonably low:

Inconvenient channels

You have to go out of your way to get hearing help. No-one wants to visit a typically over-crowded hospital, which is full of sick people. No-one nowadays wants to travel on hostile congested roads, to a hearing aid shop in a depressingly declining high street. Nor does anyone want to invite a sales person into their home, where the motivation is to spend hours convincing you to part with thousands of your savings.

Public health ‘rationing’

To access the state-funded provision in the UK, you first need to wait a couple of weeks for a low priority appointment with the Family Doctor. In 22% of cases the Family Doctor will fail to recognise a HL and will stop your journey[1e]. If referred on, the waiting time to see a public health audiologist is up to 3 months. This does not live up to the expectations of today’s middle-aged person. Such cumbersome referral process can only have been designed to limit the use of the state-funded service.

Disempowerment

The clinical investigation into a HL is privacy-intrusive and labels you as a healthcare case – i.e. as being ill. The healthcare professional controls the process and strongly influences the treatment choices. There is minimal individual choice, as most providers are resigned to prescribing from a single commercial source of solutions. The process does not permit you to feel in control of your own hearing help destiny. Using state-funded public health services, such as the NHS in the UK, makes you dependent on the system. Being directed to take handouts from the hard-pressed public purse can feel demeaning to the otherwise proudly self-sufficient individual.

Prosthetic devices

It is not without reason that the official French term is ‘prothèses auditives’ (and it is also not without reason that the marketers are hard at work trying to change this). The beige banana-shaped hearing aid is stigmatised as being in league with false teeth and prosthetic limbs. The customisation element of hearing aids shares its materials science with the dental industry; and at least one of the Big 5 hearing aid manufacturers has substantial investment in the prosthetic limbs industry. For all its good, the hearing aid is simply never going to become something that a middle-aged person aspires to associate with. This is evidenced in people with HL being prepared to pay extortionate sums for the smallest, most discrete devices that are best hidden inside or behind the ear. Many middle-aged wearers, however, will remain uncomfortably conscious about how other people perceive their prosthetic hearing aid.

prosthetic devices

The UK NHS fits 1.4 million hearing aids yearly. Data[5] from its purchasing division suggests that 99.98% are banana-shaped and 89% are beige in colour, which ironically does not represent the skin-tones in the UK population. Of the remainder 11% of colours, half are brown and others are silver grey and black. Presumably, non-white people are less likely to access the hearing help services, which is nearly as bad as the thought that non-white people are being issued with beige.

Hit-and-miss outcomes

Refer a HL patient and a hearing aid model to one audiologist and it will produce a certain outcome. Refer the same patient and the same hearing aid model to a different audiologist and it might well produce a very different outcome, ranging from very bad to very good. The current service model is highly inconsistent, which is mainly due to subjective human factors.

Outdated clinical protocol

The audiogram says something about the ears’ ability to pick up sounds, but it says nothing about the brain’s cognitive ability to hear. The standard ‘best practice’ protocol contains a series of seriously stacked tolerances: Pure tone audiometry: +/-8dB plus NAL: +/-12dB plus REM: +/-3dB. The current protocol produces nothing but a best average fitting result. Real individual amplification and compression needs can vary significantly from this average. In the most extreme cases, the stacked tolerances can deviate up to 20dB from the individual’s ideal. Deviation of up to 10dB from the individual’s ideal is common in practice. Good clinicians will therefore verify and fine-tune to speech test signals, but such clinicians are in a significant minority in adult care.

Acclimatisation

The new hearing aid will feel and sound uncomfortable at first, while the ear and the brain adjust to receiving more stimuli. In too many cases the (coun)selling consists of a pat on the back saying: “Stick with it. You will get used to it”. Some people don’t get used to it, often because the original fitting was inappropriate for the individual’s HL. An audiologist coercing a patient into accepting a mis-fitted hearing aid is nothing but an arrogant bully and is doing a dis-service. The “Stick with it. You will get used to it” approach is regrettably common practice.

Poor usability

Try observe an 85-year old person inserting and switching on a hearing aid. Instead of being a simple process, many users cannot manage this fundamental task. They keep pressing places where they believe some tiny buttons to be, but which their fingers cannot feel and their brain cannot remember what are meant to do, until suddenly some sound appears. Then freeze, don’t touch again, because you may lose the ‘some sound’. As result, many hearing aids are used mostly in sub-optimal programme and volume settings.

Manufacturer dominance

The fact that end-customers can pay anything up to £3,000 (US$3,800) for a hearing aid that costs £30 (US$38) to produce has everything to do with maximising a chain of profits. The service to people with HL appears to be a secondary motivation across the industry. The big hearing aid manufacturers are going through lengths to protect the prices, including maintaining a controlling influence over most hearing aid retailers and collaborating through shared ‘assets’[6] and a joint consortium[7,8] that keeps out new market entrants. It’s fair business, but the result is that most people with HL are economically unable to access the kind of hearing care that society needs.

Over-promising

Hearing aid technology is proclaimed to have improved leaps and bounds over the last 15 years. Yet, market data referenced to the UK’s international manufacturing association shows that the percentage of hearing aids that are returned for refunds, because customers were not entirely satisfied or did not get on with them, has increased markedly over the same period. Hearing aids with premium features, at premium prices, have a significantly higher return rate (more than 30%) compared to basic hearing aids (less than 3%). Credible studies, into the wearers’ comfort and abilities to understand speech, are unable to find any material differences between a basic £500 (US$625) hearing aid and a top-end premium £3,000 (US$3,800) hearing aid with all the latest possible bells and whistles. The differences in performance appears to exist mainly in the manufacturers’ marketing literature, where they support price inflation but not user satisfaction.

It can be argued that some of the above is accentuated in a partial language, to which I would respond is justifiable necessary. No-one can counter-argue that the existing market model is in fact effective in serving the majority of people with HL. The banana-shaped form factor has been around for 60 years and has achieved a mere 4% to 8% penetration with those in need.

Tomorrow’s market model

The new US over-the-counter (OTC) hearing aid regulation will help increase penetration and also stimulate new innovative entrants. OTC will inevitably contribute to a revolution in the established hearing help model. High-end ‘premium’ hearing aid manufacturers have already made a head start in now offering the convenience of home adjustments through your phone, which signals the beginning of the end to ever visiting an audiologist.

It is difficult to predict what tomorrow’s model will finally look like, but as a middle-aged person with HL I can easily see myself engaging with a consumer friendly health journey that looks as follows:

Self-referral

Complete a screening questionnaire, to confirm to yourself that you are one of the 90% of people with HL for whom a self-service process is suitable. Check with your Family Doctor if you think that your HL could be caused by something as trivial earwax or could maybe have a more sinister cause.

Convenient channels

Pick up a pair of hearing devices in your local supermarket’s pharmacy or optical corner; or make an informed purchase from a trusted brand on-line. The UK and most European national laws already permit this, because the medical hearing aid is not a prescription device (unlike in the US were OTC deregulation is required).

Self-funding

Empower people to resolve their own conditions, without forcing them to become labelled as a healthcare case. This enhances motivation, pride and protects the important sense of freedom that comes with being self-sufficient. Self-funded costs up to £100 (US$125) are easily tolerated. Costs up to £300 (US$380) are comfortable for most individuals in the UK. Self-funding could of course be topped up or replaced by state support for those who do not have the means.

Consistent outcomes

Self-administered tuning of the hearing device to perceived speech clarity and words recognition, instead of to inadequate pure tone beeps, can easily personalise the amplification profile to an individual’s true HL situation. Acclimatisation motivation, brain training and ongoing self-maintenance can be met through a mobile self-care app. Early studies in this area suggest that self-administered technology is better at assuring consistently good outcomes, compared to the hit-and-miss that occurs when involving a subjective human audiologist, using the wide tolerances of traditional audiometry and the NAL prescription formula.

Medical hearable

Wireless earbuds form factor

True wireless earbuds already outsell hearing aids 4-to-1 (60 million) and this is forecast to further double in the next year[9]. Their consumer electronics design is desirable to a middle-aged person. The technology can easily be upgraded with medical hearing aid functionality – minus the value destroying purely marketing features – to become classed as a medical hearable.

Beware: Do not believe in hearables marketed for ‘hearing care’, unless they can demonstrate a conformity assessment to the standards for basic safety and essential performance of medical devices.

Cost-efficiency

Cutting out the professional services elements and costly hospital overheads, or the premium rent for a high street presences, will comfortably enable a £250 (US$310) direct-to-consumer price, for a pair of medical grade wireless hearing devices. Add a TV sound streaming device for £30 (US$38). Add a companion microphone for challenging noise situations, such as busy meetings or restaurants, for £45 (US$57).

Usability

Operate the new hearing devices via an accessibility assisted smartphone app. The combined hearing aid, noise reduction and wireless earbud functionalities allows you to communicate, take telephone calls, listen to music in private, voice interface with the internet and household equipment via the single medical hearable.

The current downside to hearables is that some generations and cultures would initially consider it rude to wear earbuds while speaking to another person. Some will continue to prefer a skin-tone device that is more discrete inside or behind the ear. This perception is however changing rapidly and it is a tiny barrier that will soon resolve itself. It is for example already common-place and naturally respected that workers in open plan offices wear earbuds, to signal “please do not disturb me at the moment, I need to concentrate”.

The opposite function can be used for communicating in challenging environments, such as at large meetings or by workers in noisy restaurants and clubs. Wearing a noise reducing, speech enhancing, forward-directional listening device in such situations positively signals that “I want to communicate well with you”. Simultaneously to providing hearing help, therefore, such a device is perceivably a productivity tool for professionals. Both scenarios (hearing augmentation and hearing isolation) will help normalise hearables. The device could have a visual green-red light, to indicate whether the wearer is ready to listen or wish to be isolated.

The emergence of a consumer friendly health journey, with a medical class hearable, could foreseeably spur an uptake from under-served people who currently do not access hearing help. It is not inconceivable that global demand for such an alternative hearing help model is at least 20 million hearable units per year, including taking half of all traditional hearing aid sales. This would better serve society and people with HL. The inferred longer-term outcome from just 20 million new medical hearables, complementing the residual 8 million hearing aids, could potentially include:

    • 50% fewer people with HL feeling discriminated against in the employment market.
    • 3% reduction in overall major depression.
    • 4% reduction in overall dementia.
    • Addressing about £10 billion (US$13 billion) of the current UK costs from untreated HL.
    • Measurable improvements in World health.
    • A new platform to further evolve hearing care from.

No-one can suggest this is a bad idea, can they?

 

References:

[1] Avonum, EuroTrak – UK/2018/(a)n=921;(b)n=602;(c)n=393;(d)n=1,300;(e)n=270
[2] Livingston.G et al, ‘Dementia prevention, intervention, and care’, The Lancet, Vol. 390, No. 10113
[3] https://www.ehima.com/wp-content/uploads/2019/03/HearitReportHearingLossNumbersandCosts.pdf
[4] World Health Organisation, ‘Deafness and hearing loss’, March 2019.
[5] https://apps.nhsbsa.nhs.uk/FOI/foiRequestDetail.do?bo_id=7587
[6] http://slideplayer.com/slide/10883368/
[7] www.himpp.info
[8] https://medwatch.dk/Medico___Rehab/article9987191.ece [translate last paragraph]
[9] https://report.counterpointresearch.com/posts/report_view/Emerging_Tech/1118

This article was originally posted on LinkedIn, Frede Jensen, 12th August 2019