Notch-induced lateral inhibition compared to standard amplification lateral inhibition therapy for the treatment of chronic tinnitus: A randomised controlled trial.

purposeChronic tonal tinnitus is a distressing condition, frequently associated with hearing loss. Sound therapy delivered via hearing aids using notch-induced lateral inhibition (NILI) algorithms has been proposed as a targeted approach to reduce tinnitus perception.

methodsThis multicentre, randomized, double-blind crossover trial recruited adults with chronic tonal tinnitus and moderate hearing loss. Each participant was randomized to receive two months of auditory stimulation using either NILI or standard amplification (SA), followed by a 2-week wash-out period and crossover to the alternative protocol. The primary outcome was the change in tinnitus-related handicap (Tinnitus Handicap Inventory, THI) at two months. Secondary endpoints included patient satisfaction (visual analogue scales for discomfort and intensity), adverse events, time to first symptom improvement and sustained residual effects.

resultsTwenty-six participants were enrolled. Due to a significant treatment carryover effect, primary analyses were limited to the first treatment phase. At two months, SA yielded greater reduction in THI scores compared to NILI (mean change: -11.45 vs. 0.00; p < 0.05). Both treatment arms showed only modest improvements in tinnitus discomfort and intensity. A greater proportion of SA users reported subjective improvement (91.8% vs. 38.5% with NILI). Adverse events were mild across both interventions.

conclusionIn this well-characterized cohort, notched lateral inhibition delivered through hearing aids offered no advantage over standard amplification for reducing tinnitus-related handicap or distress. These findings underscore the importance of individualized management and signal the need for further trials to clarify which patients may benefit from algorithmic innovations in hearing aid-based tinnitus therapy.