Clinical study on the efficacy, acceptance, and safety of hearing aids in patients with mild to moderate presbyacusis

BACKGROUND: The primary objective of this trial was to demonstrate the effect of wearing a Hearing aid (HA) on improvement of hearing and comprehension in everyday life situations. METHODS: This single-center phase IV open-label clinical trial was carried out on men or women 40 years old or more, presenting mild or moderate first-degree presbyacusis. Presbyacusis was diagnosed by performance of pure-tone audiometry in silence. The main criterion was the comparison of the Glasgow Hearing Aid Benefit Profile (GHABP) before wearing HA and after a month of use and the secondary one was audiometric parameters. RESULTS: Forty-seven patients (mean age 60.0 +/- 6.9 years) were included in the study. After 4 weeks, when wearing HA, no significant difficulty remains in the patients when they watch television (GHABP situation 1) or when they have a conversation without background noise (GHABP situation 2). To have a conversation in a busy street or a shop GHABP (situation 3) 4.4% of patients still have great difficulty, as are 2.2% of them when participating in a group conversation (GHABP situation 4). The GHABP score of residual disability for the whole of the 4 situations of difficulty is 1.3 +/- 0.5, translating into no or only slight residual disability, in very significant amelioration of 1.3 +/- 0.7 points (P<0.0001), or 46.4% compared to the initial value. Audiometric parameters were also significantly improved. CONCLUSIONS: This study has allowed us to highlight from a clinical as well as an audiometric perspective the safety, effectiveness, as well as the important benefit of Sonalto (R) pre-set hearing aids on the improvement of hearing in patients presenting incipient presbyacusis.