Exploration of the Functional Effect of Modified Gain Precalculation on Soft Speech Intelligibility
1 other identifier
interventional
16
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2026
CompletedFirst Posted
Study publicly available on registry
February 5, 2026
CompletedStudy Start
First participant enrolled
April 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 30, 2026
April 24, 2026
April 1, 2026
1 month
January 28, 2026
April 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Speech intelligibility
Speech intelligibility in % will be assessed with a monosyllabic word recognition test for each of the interventional conditions
From enrollment to the end of treatment at 3 weeks
Secondary Outcomes (3)
Qualitative ratings on naturalness
From enrollment to the end of treatment at 3 weeks
Qualitative ratings on loudness
From enrollment to the end of treatment at 3 weeks
Qualitative ratings on own voice quality
From enrollment to the end of treatment at 3 weeks
Study Arms (3)
Competitor device, hearing aid with standard gain precalculation principle
ACTIVE COMPARATOREach 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
EXPERIMENTALEach 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
EXPERIMENTALEach 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sonova AG
Stäfa, 8712, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Josephine Hollenbach
Sonova AG
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical studies manager
Study Record Dates
First Submitted
January 28, 2026
First Posted
February 5, 2026
Study Start
April 20, 2026
Primary Completion (Estimated)
May 30, 2026
Study Completion (Estimated)
May 30, 2026
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share