Research AppraisalRandomised Controlled Trial

Comparison of the Hearing Benefits and User Satisfaction With Hearing Aids and Personal Sound Amplification Products: A Multicenter Prospective Randomized Crossover Trial

Journal of Korean medical scienceHan, Jae Sang, Seo, Jae-Hyun, Lee, Sumin et al.20 Apr 2026DOI

Clinical Snapshot

70CEBM
Evidence: ModerateRandomised Controlled Trial

PICO Framework

P — Population73 adults with sensorineural hearing loss
I — InterventionHearing aids (premium and basic)
C — ComparatorPersonal sound amplification products (high-end and basic)
O — OutcomesAudiologic performance (pure-tone audiometry, word recognition, speech-in-noise testing) and user satisfaction (standardized questionnaires)

Bottom Line

This multicenter crossover trial provides valuable evidence comparing hearing aids to personal sound amplification products in 73 adults with sensorineural hearing loss. The study demonstrates superior audiologic performance of hearing aids, particularly in high-frequency gain and speech-in-noise situations, along with higher user satisfaction scores. While PSAPs offer cost advantages, they appear insufficient for optimal hearing rehabilitation. The crossover design strengthens internal validity by eliminating between-subject variability, though the inability to blind participants creates inherent bias risk. For Australian clinicians, these findings support current practice patterns favoring hearing aids for hearing loss management, while acknowledging PSAPs may serve as interim solutions for cost-constrained patients. The study reinforces the importance of professional audiologic assessment and device fitting, supporting the regulatory distinction between medical devices and consumer electronics in hearing healthcare.

Evidence: Moderate

Key Findings

  • P Value: Significance levels not specified

  • Effect Size: Not specified in abstract

  • Primary Outcome: Superior audiologic performance and user satisfaction with hearing aids compared to PSAPs

  • Nnt Or Sensitivity: Not applicable - comparative effectiveness study

  • Confidence Interval: Not provided

Clinical Application

High feasibility as both device types are commercially available with established fitting protocols Relevant to Australian practice where hearing aids are subsidized through government programs but PSAPs remain unregulated alternatives. Results support current TGA regulatory framework distinguishing medical devices from consumer electronics. Adults with sensorineural hearing loss considering hearing amplification options

Abstract

BACKGROUND: While hearing aids (HAs) remain the primary intervention for hearing loss, their high cost creates barriers to access. Personal sound amplification products (PSAPs) are a more affordable alternative, but few studies have compared their efficacy to those of HAs. This multicenter, prospective, randomized, crossover trial was conducted to compare audiologic performance and user satisfaction between HAs and PSAPs to evaluate PSAP potential as alternatives for hearing rehabilitation. METHODS: A total of 73 participants with sensorineural hearing loss was enrolled. Participants used one hearing device (HA or PSAP) for 3 months before changing to the other for 3 months. Outcome measures were pure-tone audiometry, word recognition score, and Hearing in Noise Test score. Subjective satisfaction was measured using standardized questionnaires-the Abbreviated Profile of Hearing Aid Benefit and the International Outcome Inventory for Hearing Aids-and two custom surveys. RESULTS: HAs showed superior performance in high-frequency functional gain, speech perception in noise, and user satisfaction compared to PSAPs. Premium HAs demonstrated better performance than basic HAs, while basic HAs significantly outperformed both high-end and basic PSAPs. No significant differences were found between high-end and basic PSAPs. CONCLUSION: The superior audiologic performance of and user satisfaction with HAs compared to PSAPs support their continued preference for hearing rehabilitation. Although PSAPs offer a more affordable option, they may not meet the needs of individuals with hearing loss, particularly in terms of high-frequency gain and speech perception. TRIAL REGISTRATION: iCreaT Identifier: C220078.

References

  1. 1.Han, J. S., Seo, J. H., Lee, S., Song, J. J., Moon, I. J., Park, M. K., & Park, Y. H. (2026). Comparison of the hearing benefits and user satisfaction with hearing aids and personal sound amplification products: A multicenter prospective randomized crossover trial. Journal of Korean Medical Science, 41, e131. https://doi.org/10.3346/jkms.2026.41.e131
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