Clinical evaluation of an over-the-counter hearing aid (TEO First®) in elderly patients suffering of mild to moderate hearing loss
To deal with the high prevalence of presbycusis, its direct influence on autonomy in elderly and the low rate of hearing aid usage relative to the prevalence of hearing loss, Tinteo – Personal Sound© company has developed a new OTC hearing aid named TEO First®. The primary objective of our study was to assess the quantitative hearing benefit provided by the use of TEO First®. Audiometric evaluation was completed by an assessment concerning the acceptability of this device, its influence on patient’s quality of life and its impact on the project to switch for permanent hearing aid.
Our study has shown an improvement of hearing with TEO First® especially on speech perception. The use of this device has also improved the patients’ quality of life. Thus, considering that in France low affordability is the top reason not to have hearing aids for 78 % of hearing aid candidates [6] the OTC hearing aid TEO First® appears to be a new effective tool in hearing rehabilitation. This low cost device could potentially facilitate the first step towards hearing rehabilitation. It seems to be a crucial element if we consider the significant consequences of hearing loss, especially the loss of autonomy [3–5].
One of the limitation of our study is the absence of control group. As demonstrated by Munro and colleagues, it is important to control for placebo effects in hearing aid trials and to interpret cautiously any hearing aid trial that did not control for this effect [16, 17]. Nevertheless, the placebo effect described by these study is marginal (+6 % for speech-in-noise performance). Considering the importance of the improvement for the speech comprehension in noisy environment (+47.7 %) in our study, we can consider that the placebo effect does not modify the interpretation concerning our results.
Despite a significant improvement of audiometric parameters with TEO First®, the post-use acceptability was low. This result was consistent with a recent publication indicating a low to moderate interest of bilateral hearing aids for the patients in the four situations explored by the GHABP [18]. This may be due to the very good impression and the great initial expectancy in the performance of TEO First®. Indeed, even if this device has proved its efficacy, it cannot substitute the classical prosthetic devices which perform much better. This gap between initial expectations and real performance can partially explain the low final acceptability.
Moreover, the duration of the study and the small number of participants mean that this study has assessed short term outcomes only. Further studies are needed to confirm these findings and to assess the long term impact of the device.
Nowadays, there are three major obstacles for a massive use of hearing aid. The first is the cost of the devices. In France, the average selling price is 1500 to 1900 euros, with a very high co-payment borne by the patient (91 % after social security reimbursement) [19, 20]. The second is the lack of information and effective screening in target populations with approximatively one third of the elderly people having undiagnosed hearing loss [21]. Indeed, because of the gradual progression of hearing impairment, people may delay or fail to seek professional help. The last is the psychological non-acceptance of the hearing aid devices.
OTC hearing aids could partially remove the first obstacle allowing an easier access to hearing aid devices. Indeed, this category of devices is clearly targeting a low cost market segment compared to digital prosthetic hearing aids. Moreover, OTC hearing aids could also partially solve the problem of lake of information by facilitating access to hearing professionals and therefore improving information as well as screening of deafness.
The satisfaction of the patients with those devices could lead to proposing a digital prosthetic hearing aid to improve hearing rehabilitation. Indeed, to ensure optimum performance of the device, it was necessary to involve the expertise of an audiologist who performed hearing evaluation and adjusted the settings of the device. Nevertheless, our study shows that the wish to use hearing aids continuously was not changed by the use of this OTC hearing aid. Yet, OTC hearing aids could be sufficient hearing rehabilitation devices for certain populations of patients, for example, for financially constrained patients and for those who do not need individual adjustment of digital prosthetic hearing aids. For example, if the patient has difficulties manipulating the device, or in case of cognitive impairment.