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

April 21, 2026 updated by: Sebastian Griepentrog
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: 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.
Device: 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.
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.
Device: 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 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech intelligibility
Time Frame: From enrollment to the end of treatment at 3 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative ratings on naturalness
Time Frame: From enrollment to the end of treatment at 3 weeks
Sound Signals will be rated in terms of naturalness on a scale from 0 - 100 in increments of 1 for each interventional condition
From enrollment to the end of treatment at 3 weeks
Qualitative ratings on loudness
Time Frame: From enrollment to the end of treatment at 3 weeks
Sound Signals will be rated in terms of perceived loudness on a scale from 1 - 5 in increments of 1 for each interventional condition
From enrollment to the end of treatment at 3 weeks
Qualitative ratings on own voice quality
Time Frame: From enrollment to the end of treatment at 3 weeks
Own voice will be rated in terms of perceived bothersomeness on a scale from 1 - 5 in increments of 1 for each interventional condition
From enrollment to the end of treatment at 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sebastian Griepentrog

Investigators

  • Principal Investigator: Josephine Hollenbach, Sonova AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2026

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

May 30, 2026

Study Registration Dates

First Submitted

January 28, 2026

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRF-35145

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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