Exploration of the Functional Effect of Modified Gain Precalculation on Soft Speech Intelligibility

Sponsor
Sebastian Griepentrog
Study ID
NCT07388784
Status
Recruiting
Apply to this trial

Conditions

  • Hearing Loss

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Competitor device, hearing aid with standard gain precalculation principle — DEVICE
    Each participant will be fitted with two different pairs of hearing aids with different gain precalculation principles. Gain precalculation applies the amplification of sound signals in the hearing aid. The active comparator condition is the state of the art hearing aid gain precalculation from a competitor device.
  • Hearing aid with gain precalculation principle 1 — DEVICE
    Each participant will be fitted with two different pairs of hearing aids with different gain precalculation principles. Gain precalculation applies the amplification of sound signals in the hearing aid. The experimental conditions vary in their parametrization to result in different degrees of added amplification.
  • Hearing aid with gain precalculation principle 2 — DEVICE
    Each participant will be fitted with two different pairs of hearing aids with different gain precalculation principles. Gain precalculation applies the amplification of sound signals in the hearing aid. The experimental conditions vary in their parametrization to result in different degrees of added amplification.

Study Details

An exploratory investigation of gain precalculation principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. These gain precalculation principles are enabled by respective hearing instrument technologies and hearing instrument algorithms. The aim of the study is to investigate and assess strength and weaknesses of these gain precalculation principles in terms of speech intelligibility to determine their application in hearing instruments (Phase of development). Objective laboratory measurements as well as subjective ratings will be carried out. This will be a controlled, single blinded and randomized active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarter based in Stäfa.

Key Dates

First listed
Feb 5, 2026
Start date
Apr 20, 2026
Status verified
Apr 2026
Primary completion
May 30, 2026
Completion
May 30, 2026

Study Design

Enrollment
16 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Competitor device, hearing aid with standard gain precalculation principle
    Each participant will be fitted with two different pairs of hearing aids with different gain precalculation principles. Gain precalculation applies the amplification of sound signals in the hearing aid. The active comparator condition is the state of the art hearing aid gain precalculation from a competitor device.
  • Experimental: Hearing aid with gain precalculation principle 1
    Each participant will be fitted with two different pairs of hearing aids with different gain precalculation principles. Gain precalculation applies the amplification of sound signals in the hearing aid. The experimental conditions vary in their parametrization to result in different degrees of added amplification.
  • Experimental: Hearing aid with gain precalculation principle 2
    Each participant will be fitted with two different pairs of hearing aids with different gain precalculation principles. Gain precalculation applies the amplification of sound signals in the hearing aid. The experimental conditions vary in their parametrization to result in different degrees of added amplification.

Primary Outcome Measure

Speech intelligibility [ Time Frame: From enrollment to the end of treatment at 3 weeks ]

Central Contacts

Related Studies