Feasibility of a Smartphone-Based Hearing Aid App for Mild to Moderate Hearing Loss: A Prospective, Randomized, and Controlled Multicenter Study (Preprint) (2023)

<sec> <title>BACKGROUND</title> 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 applications 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. </sec> <sec> <title>OBJECTIVE</title> We compared the audiological performance between a SHAA and a conventional HA in a prospective, randomized, and controlled multicenter study. </sec> <sec> <title>METHODS</title> Patients with mild to moderate hearing loss were prospectively enrolled from two tertiary hospitals and randomly assigned to either a SHAA (Petralex, IT4YOU Corp. LLC, Saveni, Romania,) or a conventional HA (Siya 1 miniRITE, Oticon, Smorum, Denmark). 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 (REMs), and hearing-in-noise tests (HINTs). Subjective satisfaction was evaluated using the Abbreviated Profile of Hearing Aid Benefit (APHAB) and the International Outcome Inventory for Hearing Aids (IOI-HA). </sec> <sec> <title>RESULTS</title> In total, 63 participants were screened and 38 participants completed the study. In sound field audiometry testing, the SHAA showed a 20–60 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 REMs), 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 HINTs. The IOI-HA scores were significantly improved by both the HA and SHAA versus unaided conditions. Among the SHAA users, 37%, 42%, 24%, and 32% 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 two study groups. </sec> <sec> <title>CONCLUSIONS</title> The HA showed better performance than the SHAA in word recognition and HINTs. 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 poor performance when compared to 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 SHAA is needed to improve the sound quality of mid- to high-frequency sounds and to overcome noisy environments. </sec>