Practical Guidelines for Smartphone-Based Hearing Aid Application and Personal Sound Amplification Device Usage to Correct Hearing Loss in Korea Based on a Randomized Controlled Trial by the Patient-Centered Clinical Research Coordinating Center.

The prevalence of mild-to-moderate hearing loss is increasing due to noise exposure and an expanding elderly population. Despite the benefits of hearing aids, many individuals avoid them due to cost and incomplete awareness, opting instead for smartphone-based hearing aid applications (SHAAs) and personal sound amplification products (PSAPs). However, these devices are currently lacking official approval for medical use. The study results, together with roundtable discussions organized by the Patient-Centered Clinical Research Coordinating Center (PACEN) and recent research findings, were reviewed to develop clinical guidelines. The roundtable discussions involved seven otology experts and one lay representative and focused on defining PSAPs and establishing minimum requirements for their use by patients with hearing loss. Hearing aids were found to effectively address all types of hearing loss and improve speech recognition in noisy environments. In contrast, SHAA and PSAP are effective only under specific conditions: SHAA for mild loss and PSAP for mild-to-moderate loss. Both devices perform poorly in noisy settings and lack noise processing features. Hearing aids are recommended as the most effective and versatile option for auditory rehabilitation, whereas SHAA and PSAP should only be considered under defined conditions when hearing aids are impractical. Continued updates and cost-effectiveness evaluations will be required as technologies advance.