Modified hearing-aid gain settings to improve understanding of soft speech
Exploration of the Functional Effect of Modified Gain Precalculation on Soft Speech Intelligibility
This study will test different hearing-aid gain precalculation settings in adults with hearing loss to see if they help people understand soft speech better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Sonova AG Industry-sponsored |
| Locations | 1 site (Stäfa) |
| Trial ID | NCT07388784 on ClinicalTrials.gov |
What this trial studies
Researchers will compare several gain precalculation principles implemented in CE‑labelled Sonova hearing instruments (and a competitor device) using a randomized, single‑blinded, active‑comparator design at a single site. Adult participants with hearing loss whose audiograms fall within the devices' fitting range will undergo objective laboratory measurements and give subjective ratings of speech intelligibility. The trial will focus on understanding of soft speech and collect both performance data and listening impressions. Results are intended to inform whether these precalculation approaches should be applied in commercial hearing instruments.
Who should consider this trial
Good fit: Ideal candidates are German‑speaking adults (18+) with hearing loss within the hearing aids' fitting range who can complete hearing tests and questionnaires and describe listening experiences.
Not a fit: People with unaidable or highly asymmetrical hearing loss, active otologic disease, acute tinnitus, vertigo, auricle deformities preventing device placement, or material allergies are unlikely to benefit or to be eligible.
Why it matters
Potential benefit: If successful, the tested gain precalculation settings could improve users' ability to hear and follow soft speech in everyday situations.
How similar studies have performed: While prior work has explored gain‑setting and prescription methods, this specific modified gain precalculation approach in CE‑labelled Sonova devices is exploratory and not yet established in published clinical results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Hearing impaired adult at a minimum age of 18 years * Good written and spoken german skills * Ability to fill in a questionnaire concientiously * Ability to produce a reliable hearing test result * Ability to describe listening impressions / experiences * Audiogram is in the fitting range of the hearing aids Exclusion Criteria: * Unaidable hearing loss in one or both ears * Auricle deformities that prevent secure placement of the investigational device * Acute tinnitus in one or both ears * Unwillingness to test the investigational device * Asymmetrical hearing loss * Hypersensitivity or allergy against synthetic materials * Symptoms of vertigo or dizziness * Suffering from any otologic disease
Where this trial is running
Stäfa
- Sonova AG — Stäfa, Switzerland (Recruiting)
Study contacts
- Principal investigator: Josephine Hollenbach — Sonova AG
- Study coordinator: Sebastian Griepentrog
- Email: sebastian.griepentrog@sonova.com
- Phone: 004158928
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.