Hearing LossNCT07388784
Exploration of the Functional Effect of Modified Gain Precalculation on Soft Speech Intelligibility
A study testing Competitor device, hearing aid with standard gain precalculation principle, Hearing aid with gain precalculation principle 1 and Hearing aid with gain precalculation principle 2 in people with Hearing Loss, run by Sebastian Griepentrog at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Competitor device, hearing aid with standard gain precalculation principle, Hearing aid with gain precalculation principle 1 and Hearing aid with gain precalculation principle 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Apr 2026to 22 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hearing Loss
- Being tested
- Competitor device, hearing aid with standard gain precalculation principle, Hearing aid with gain precalculation principle 1, Hearing aid with gain precalculation principle 2
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Competitor device, hearing aid with standard gain precalculation principleDevice
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 1Device
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 2Device
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 group | Role | What they receive |
|---|---|---|
| Competitor device, hearing aid with standard gain precalculation principle | Active comparator | 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. Receives: Device: Hearing aid with gain precalculation principle 1; Device: Hearing aid with gain precalculation principle 2 |
| Hearing aid with gain precalculation principle 1 | Experimental | 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. Receives: Device: Competitor device, hearing aid with standard gain precalculation principle |
| Hearing aid with gain precalculation principle 2 | Experimental | 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. Receives: Device: Competitor device, hearing aid with standard gain precalculation principle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech intelligibility
Speech intelligibility in % will be assessed with a monosyllabic word recognition test for each of the interventional conditions
Measured: From enrollment to the end of treatment at 3 weeks
Secondary outcomes (3)
Qualitative ratings on naturalness
Sound Signals will be rated in terms of naturalness on a scale from 0 - 100 in increments of 1 for each interventional condition
Measured: From enrollment to the end of treatment at 3 weeks
Qualitative ratings on loudness
Sound Signals will be rated in terms of perceived loudness on a scale from 1 - 5 in increments of 1 for each interventional condition
Measured: From enrollment to the end of treatment at 3 weeks
Qualitative ratings on own voice quality
Own voice will be rated in terms of perceived bothersomeness on a scale from 1 - 5 in increments of 1 for each interventional condition
Measured: From enrollment to the end of treatment at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start20 Apr 2026
- Primary completion22 Jul 2026
- Study completion22 Jul 2026
Why it stopped: Despite heavy recruiting efforts not enough participants could be found
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant will be treated with each gain precalculation principle in a randomized order
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sebastian Griepentrog
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Sebastian Griepentrog, Sonova AG
- Investigators
- Josephine Hollenbach, Principal investigator, Sonova AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388784
- Sponsor's protocol ID
- SRF-35145
- Status last verified
- Apr 2026
- First submitted
- 28 Jan 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Functional Effect of Modified Gain Precalculation on Soft Speech Intelligibility
- ClinicalTrials.gov ID
- NCT07388784
- Acronym / sponsor ID
- SRF-35145
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Despite heavy recruiting efforts not enough participants could be found
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Sebastian GriepentrogIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 22 Jul 2026 (actual)
- Study completion
- 22 Jul 2026 (actual)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Each participant will be treated with each gain precalculation principle in a randomized order
| Arm | Type | Receives |
|---|---|---|
| Competitor device, hearing aid with standard gain precalculation principle | Active comparator | Device: Hearing aid with gain precalculation principle 1, Device: Hearing aid with gain precalculation principle 2Each 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 | Experimental | Device: Competitor device, hearing aid with standard gain precalculation principleEach 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 | Experimental | Device: Competitor device, hearing aid with standard gain precalculation principleEach 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Competitor device, hearing aid with standard gain precalculation principleEach 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, Hearing aid with gain precalculation principle 2 |
| Hearing aid with gain precalculation principle 1Each 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 |
| Hearing aid with gain precalculation principle 2Each 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 |
Primary outcome
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
3 secondary outcomes
Qualitative ratings on naturalness
Time frame: 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
Qualitative ratings on own voice quality
Time frame: From enrollment to the end of treatment at 3 weeks
Results and safety
The study was stopped early (reason given: Despite heavy recruiting efforts not enough participants could be found). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josephine Hollenbach principal investigator
Sonova AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Competitor device, hearing aid with standard gain precalculation principle, Hearing aid with gain precalculation principle 1 and Hearing aid with gain precalculation principle 2 in people with Hearing Loss, run by Sebastian Griepentrog at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Despite heavy recruiting efforts not enough participants could be found). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech intelligibility (time frame: From enrollment to the end of treatment at 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.