Smartphone-bundled earphones as personal sound amplification products in adults with sensorineural hearing loss

Lin, Heng-Yu Haley; Lai, Hoi-Shan; Huang, Chii-Yuan; Chen, Chih‐Hao; Wu, Shang-Liang; Lee, Fa-Yauh; Lai, Ying‐Hui

doi:10.1016/j.isci.2022.105436

Cited by 9 publications

(4 citation statements)

References 27 publications

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“…Bose, the first company selling the OTC hearing aid, sold its self-fitting hearing aid technology to Lexie (part of HearX) and totally exited the hearing aid market. Apple's absence in the OTC hearing aid market is particularly surprising, because not only do they own more hearing aid-related patents than any hearing aid manufacturer (Zeng, 2015), but also are more than capable of producing a premiumquality hearing aid (Lin et al, 2022).…”

Section: Otc Hearing Aid Market Trendmentioning

confidence: 99%

Over-the-counter hearing aids: implementations and opportunities

Chung,

Zeng

2024

Front. Audiol. Otol.

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After decades of effort by shareholders, including government agencies, patient advocacy groups, and professional organizations, the U.S. Food and Drug Administration (FDA) established a new medical device category for over-the-counter (OTC) hearing aids on October 17, 2022. This FDA regulation allows adults aged 18 years or older with perceived mild-to-moderate hearing loss to purchase OTC hearing aids without a prescription or even a hearing test. The goal is to increase hearing aid accessibility, potentially leading to improved hearing and a better quality of life. In our analysis of the FDA Establishment Registration & Device Listing database, we found that the current OTC hearing aid market is still dominated by traditional hearing aid manufacturers, with limited disruptor from major consumer electronics and startup companies. Our technological analyses showed that the relatively high-level output specification without gain limitation allows sufficient amplification even for people with severe-to-profound hearing loss. Additionally, borrowing from the cochlear implant mapping strategy, we propose novel amplification algorithms for fitting OTC hearing aids without an audiogram. We argue that smartphones and true-wireless-stereo earbuds can functionally serve as OTC hearing aids, further increasing accessibility and affordability while reducing the stigma associated with hearing aids, especially in low- and mid-income countries. By treating more people at a younger age with less hearing loss than traditional prescription hearing aids, OTC hearing aids can potentially have a significant impact beyond hearing care, such as delaying or preventing cognitive decline in the elderly.

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Section: Otc Hearing Aid Market Trendmentioning

confidence: 99%

Over-the-counter hearing aids: implementations and opportunities

Chung,

Zeng

2024

Front. Audiol. Otol.

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“…However, only a few studies of SHAAs have been conducted. Lin et al [35] reported that smartphone-bundled earphones can be used as PSAPs for mild-to-moderate hearing loss. They used AirPods Pro (Apple Inc) and compared it to 5 other PSAPs.…”

Section: Comparisons With Previous Researchmentioning

confidence: 99%

Feasibility of a Smartphone-Based Hearing Aid App for Mild-to-Moderate Hearing Loss: Prospective Multicenter Randomized Controlled Trial

Park¹,

Jo²,

Seo³

et al. 2023

JMIR Mhealth Uhealth

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Background Hearing loss is a growing health concern worldwide. Hearing aids (HAs) are the treatment of choice for hearing rehabilitation in most cases of mild-to-moderate hearing loss. However, many patients with hearing loss do not use HAs due to their high cost, stigma, and inaccessibility. Since smartphones are widely used, many apps that mimic the amplification function of HAs have been introduced. Smartphone-based HA apps (SHAAs) are affordable and easy to access. However, the audiological benefit of SHAAs has not been determined. Objective We compared the audiological performance between an SHAA and a conventional HA in a prospective, multicenter randomized controlled trial. Methods Patients with mild-to-moderate hearing loss were prospectively enrolled from 2 tertiary hospitals and randomly assigned to either an SHAA (Petralex; IT4YOU Corp LLC) or a conventional HA (Siya 1 miniRITE; Oticon A/S). For the cross-over study design, participants used the alternate device and repeated the same 2-month trial. Audiological measurements were obtained using hearing tests, real-ear measurements, and the hearing-in-noise test (HINT). Subjective satisfaction was evaluated using the Abbreviated Profile of Hearing Aid Benefit (APHAB) and International Outcome Inventory for Hearing Aids (IOI-HA). Results Overall, 63 participants were screened and 38 completed the study. In sound-field audiometry testing, the SHAA showed a 20- to 60-dB gain in the low-to-high frequencies of the hearing threshold level. The HA provided adequate gain in the middle-to-high frequencies (55, 65, and 75 dB in real-ear measurements), which is the sound level for most speaking volumes. However, the SHAA could not improve word recognition at 50 dB. The HA showed better audiological performance than the SHAA in both quiet and noisy conditions in the HINT. The IOI-HA scores were significantly improved by both the HA and SHAA versus unaided conditions. Among the SHAA users, 37% (14/38), 42% (16/38), 24% (9/38), and 32% (12/38) showed improvement in APHAB scores for ease of communication, reverberation, background noise, and aversiveness of sounds, respectively. There were no differences in adverse events between the 2 study groups. Conclusions The HA showed better performance than the SHAA in word recognition and the HINT. However, the SHAA was significantly better than unaided hearing in terms of amplification. The SHAA may be a useful hearing assistance device for patients with mild-to-moderate hearing loss when listening to soft sounds in quiet conditions. The SHAA demonstrated poorer performance than the HA in the mid- to high-frequency sounds that are important for word recognition, sound quality, and hearing in noisy conditions. Further development of the signal technology of SHAAs is needed to improve the sound quality of mid- to high-frequency sounds and overcome noisy environments.

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“…Currently, there are several hearing devices on the market, of which some are medical devices intended for individuals with hearing loss and regulated by the FDA (i.e., prescription hearing aids, self-fitting OTC hearing aids, pre-set OTC hearing aids), and other devices that serve as hearing enhancement devices for individuals with normal hearing who have an average hearing thresholds of 25 dB or better in frequencies 500 Hz, 1,000 Hz, 2000 and 4,000 Hz (i.e., PSAPs, hearables) or those used mainly for entertainment purpose (i.e., consumer audio devices) ( Manchaiah et al, 2023 ) ( Figure 1 ). Some manufacturers are blurring the lines between these categories and offering sound enhancement and personalization of acoustic output for persons with hearing loss using smartphone-based earphones with an accompanying smartphone app ( Lin et al, 2022 ). Moreover, studies have documented that people with hearing loss tend to use devices such as PSAPs and hearables which are meant to be for people with normal hearing ( Kochkin, 2010 ; Manchaiah et al, 2019 ).…”

Section: Introductionmentioning

confidence: 99%

Prioritizing research on over-the-counter (OTC) hearing aids for age-related hearing loss

2023

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Hearing aids are the most commonly used treatment for people with age-related hearing loss, however, hearing aid uptake is low, primarily due to high cost of the device, stigma, and a lack of perceived need. To address accessibility and affordability issues, the U.S. Food and Drug Administration created a new over-the-counter (OTC) hearing aid category. Various types of hearing devices are available for both individuals with hearing loss and for those with normal hearing, as hearing enhancement devices. Hearing aids (i.e., prescription hearing aids, self-fitting OTC hearing aids, and pre-set OTC hearing aids) are regulated by the FDA. The purpose of this article is to (a) provide a summary of existing research on direct-to-consumer (DTC) hearing devices such as Personal Sound Amplification Products (PSAPs) that informs OTC service delivery models; (b) provide an update on existing and ongoing randomized controlled trials on currently marketed OTC hearing aids; and (c) highlight the need for immediate research on OTC hearing aids and service delivery models to inform policy and clinical care. It remains to be seen what effect OTC hearing aids have on improving the uptake of hearing aids by individuals with mild-to-moderate hearing loss. However, there is scant research on all aspects of OTC hearing aids that are currently on the market. We conclude that high quality independent research must be prioritized to supplement evidence provided by the OTC hearing aid manufacturers for regulatory approval purposes.

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Smartphone-bundled earphones as personal sound amplification products in adults with sensorineural hearing loss

Cited by 9 publications

References 27 publications

Over-the-counter hearing aids: implementations and opportunities

Over-the-counter hearing aids: implementations and opportunities

Feasibility of a Smartphone-Based Hearing Aid App for Mild-to-Moderate Hearing Loss: Prospective Multicenter Randomized Controlled Trial

Prioritizing research on over-the-counter (OTC) hearing aids for age-related hearing loss

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