Hearing aids: OTC ones work well

 A recent article found the benefit of over-the-counter self-fitting hearing aids to be the same as for audiologist-fitted hearing aids, in a South African study (see hearing aid OTC vs prescribed JAMAoto2023 in dropbox, or doi:10.1001/jamaoto.2023.0376) 

 

Details: 

-- 68 adults with self-perceived mild to moderate hearing loss were randomly assigned to either self-fitting or audiologist-fitted hearing aids, from April to September 2022 

-- participants were at least 18 years old, recruited by advertisements, and had no history of outer or middle ear disease in the 90 days before the study. Those with either no hearing loss or severe hearing loss at baseline were excluded. All had bilateral hearing loss 

-- 52% men, median 64 years old; groups well-balanced at baseline, including for the 4-frequency pure-tone average;  63% of participants felt they had little trouble from hearing loss, 38% a lot; 75% were new hearing aid users 

-- the self-fitting hearing aids were FDA approved in 2022 (note: these were not the personal sound amplification products (PSAPs))

-- the hearing aid used in this study was the Lexie Lumen, and participants were required to download the smart phone App for this hearing aid and follow instructions on how to fit the hearing aid

      -- these are self-fitting behind-the-ear digital hearing aids, approved by the FDA, with 16 channels, a wide-dynamic range compression, adaptive directionality, and noise reduction 

-- participants in the audiologist-fitted group were fitted with these same hearing aids by research audiologists, using a calibrated audiometer in a soundproof booth

-- participants in the self-fitting group had no assistance by the research audiologist

-- all participants completed a 2-week take-home field trial without any support, then both groups had access to fine-tuning after that 2-week trial, provided remotely for the self-fitting group and by the audiologist for the audiologist-fitted group 

-- final assessment was done after an additional 4 weeks 

 

-- main outcome: self-reported hearing aid benefit, measured through the Abbreviated Profile of Hearing Aid Benefit score (the APHAB assessed the subscales of ease of communication, reverberation, background noise, and aversiveness)  

-- secondary outcome: the International Outcome Inventory for Hearing Aids (IOI-HA) and speech recognition in a noisy environment measured using an abbreviated speech-in-noise test and a digits-in-noise test 

-- all measures were completed at baseline, at 2 weeks, and at 6 weeks 

 

Results: 

-- at 2 weeks: self-fitting group fared better for APHAB and IOI-HA (meaningfully better performance in background noise and global benefit), but not speech recognition. The IOI-HA evaluation found that participants who were in the self-fitting group reported using their hearing aids longer per day than those in the audiologist-fitted group 

-- at 6 weeks: no meaningful differences were evident between the groups on any outcome measures, though the self-fitting group still did fare a little better in APHAB 

-- adverse events: one patient in the self-fitting group developed a middle ear infection 

 

Commentary: 

-- hearing loss is quite common, and is associated with an array of quality-of-life issues, especially in the elderly, including social isolation, deterioration of cognitive function, etc. 

-- most people have permanent sensorineural hearing loss, amenable to hearing aid improvement 

-- but, only about 20% of US adults with hearing loss actually have hearing aids 

-- until recently, the only way to get hearing aids was through an audiologist, and the cost of audiologist-fitted hearing aids has been prohibitive for many 

-- in 2017 the FDA passed the Reauthorization Act directing the creation of an OTC hearing aid category, and final regulations were published and went into effect in October 2022 

--self-fitting hearing aids are supposed to have:  

    -- either an automated or in-situ option (using in-situ threshold measurements and a proprietary algorithm to program them)

    -- the ability to operate without clinician assistance 

    -- wearer options to alter settings using accompanying controls or software through a smart phone

 

-- the Lexie Lumen hearing aids are still quite expensive at $799 per pair (though audiologist-fitted ones are typically several thousands of dollars)

-- the App is only available in English at this point, though I am told (by the company) it is very easy to use, with simple dials to change the volume, the bass or treble, and a selection of 6 different environments to modify the function (e.g. noisy indoor, everyday use, outdoor use, music, etc) 

 

-- It was interesting in this study that the people who fitted themselves for the hearing aids did better than those fitted by an audiologist, a finding consistent in other arenas where patient empowerment may lead to better outcomes (eg, some studies have shown that patients given blood pressure cuffs to check their own blood pressures were also more adherent with BP medications). Though at 6 weeks in this hearing aid study, there really were not any clinically meaningful differences between the groups 

    -- similarly, it was notable that at the 2-week assessment, the frequency of requests for hearing aid adjustment and support was 66% of those fitted by an audiologist and 6% and those who did it themselves (again ?related to patient self-empowerment)

-- There have been a few other studies in the past, using somewhat different methodology including different hearing aids, that also found basically not much difference between self-fitting or audiologist-fitting approaches 

Limitations: 

-- the results of the study were based on a single brand of self-fitting hearing aids: Lexie Lumen. so cannot generalize these results to all of them (though presumably the FDA criteria need to be met)

    -- for more on the FDA statements on OTC hearing aids, see https://www.fda.gov/news-events/press-announcements/fda-finalizes-historic-rule-enabling-access-over-counter-hearing-aids-millions-americans and  https://www.fda.gov/medical-devices/consumer-products/hearing-aids ; though to my checking around, it does not seem that there are any real studies comparing the OTC to the expensive audiologist ordered ones of the past. just lots of public comments on the OTC ones

    -- that being said, these OTC ones are only for those with mild-to-moderate hearing loss. and it seems that if they work well enough, that is probably sufficient...

-- the requirement to download and use the smartphone App does limit generalizability to those without smartphones (which is more likely in the elderly population, who would benefit most) as well as those who do not have sufficient education or ability or knowledge of the languages available for the App to use the smartphone App well

    -- at least for the Lexie hearing aids, the App is only in English

-- the cost is still likely to be a problem for many people (and especially the elderly, again who would benefit most, and tend to have a significantly lower income) 

-- there can be a problem with just buying the hearing aids OTC: as people get older, their ear wax gets drier and more impacted in their canals. And placing an object in the ear (Q-tips, but perhaps also hearing aids) might push the wax in further and potentially occlude the passageway. so, it would be great if people had their ears checked first to make sure there is no wax buildup (or significant pathology). perhaps where they buy the hearing aids?? and this does reinforce that we clinicians do check patients' ears (especially for older patients) as part of their exams

    -- i have found that liquid colace (a very cheap OTC bottle) is very effective in both dissolving large wax build-up as well as maintenance treatment every couple of weeks to maintain open ear canals

so, an intriguing study that should be replicated for other hearing aids (they are not all the same or likely have the same electronics or easy-to-use Apps). but at least there is a viable, functional option after a decade long fight for them, specifically for those >18yo who have self-perceived mild-to-moderate hearing loss. and, i think, this study also provides another example of the importance of empowering patients in their self-care

geoff

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