Hearing LossNCT06992310
Exploration of the Functional Effect of Different Hearing Aid Noise Reduction Algorithms in an Ecologically Valid Conversational Situation
A study testing Hearing Aid with standard noise reduction (NR_1), Hearing Aid with NR_2 and Hearing Aid with NR_3 in people with Hearing Loss, run by Sebastian Griepentrog at 1 site in Switzerland.
Trial summary
A methodical evaluation of sound changing 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?
- Hearing Aid with standard noise reduction (NR_1), Hearing Aid with NR_2 and Hearing Aid with NR_3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2025to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Good written and spoken German language skills
- No suffering from any speech disorders
- Experienced hearing aid user (min. 6 months)
- Ability to stand and walk during the experiment
- Ability to fill in a questionnaire conscientiously
- Ability to produce a reliable hearing test result
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- Ability to describe listening experiences/impressions
- The audiogram is in the fitting range of the hearing aid
- The audiogram is in the range of mild to moderate hearing losses (N2 - N4)
- Hearing loss in both ears
- Informed consent form
Who cannot join
- Contraindications to the medical device
- Unaidable hearing loss in one or both ears
- Acute tinnitus (in either one ear and occurrence for less than 3 months)
- Anatomical deformity of one or both ears
- Single-sided deafness
- Unwillingness to wear the investigational device during the investigational visits
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- Active pacemaker implant
- Ear canals are too narrow to take ear impressions
- Ear canals are too narrow for the use of customized earpieces
- Uncomfortable loudness threshold less than 80 dB for at least one measured frequency
- Known hypersensitivity or allergy against synthetic materials
- Acute symptoms of vertigo or dizziness
- Reported Parkinson's disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Sonova AG
Stäfa, 8712
Sebastian Griepentrog, 004158928 ext. 8676, sebastian.griepentrog@sonova.com
About this study
A methodical evaluation of sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. These sound changing principles are enabled by respective hearing instrument technologies and hearing instrument algorithms. The aim of the study is to investigate and asses strength and weaknesses of these novel sound changing principles in terms of hearing performance 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
- Hearing Aid with standard noise reduction (NR_1), Hearing Aid with NR_2, Hearing Aid with NR_3
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing Aid with standard noise reduction (NR_1)Device
Each participant will be fitted with the 3 different noise reduction (sound changing) principles on the same hearing aid, saved to 3 manual programs (ensures exact same hearing loss compensation for each intervention).
Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort.
The active comparator condition is the state of the art Noise Reduction principle to mimic the natural directivity of the outer ear.
Hearing Aid with NR_2Device
Each participant will be fitted with the 3 different noise reduction (sound changing) principles on the same hearing aid, saved to 3 manual programs (ensures exact same hearing loss compensation for each intervention).
Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort.
The experimental conditions vary in their parametrization to result in different degrees of noise suppression and good speech quality.
Hearing Aid with NR_3Device
Each participant will be fitted with the 3 different noise reduction (sound changing) principles on the same hearing aid, saved to 3 manual programs (ensures exact same hearing loss compensation for each intervention).
Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort.
The experimental conditions vary in their parametrization to result in different degrees of noise suppression and good speech quality.
| Study group | Role | What they receive |
|---|---|---|
| Hearing aid standard NR_1 | Active comparator | Hearing Aid with standard noise reduction (NR) serves as reference condition Receives: Device: Hearing Aid with standard noise reduction (NR_1) |
| Hearing Aid with NR_2 | Experimental | NR_2: Noise reduction principle 2 Receives: Device: Hearing Aid with NR_2 |
| Hearing Aid with NR_3 | Experimental | NR_3: Noise reduction principle 3 Receives: Device: Hearing Aid with NR_3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Own Voice Level
Changes to the participants' own voice level (RMS in dB) during a conversation in noise in the laboratory will be recorded in each interventional condition.
Measured: 3 weeks
Secondary outcomes (2)
Interpersonal distance
Changes to the participants' interpersonal distance (in m) during a conversation in noise in the laboratory will be measured in each interventional condition.
Measured: 3 weeks
Qualitative interview form
A qualitative questionnaire with predefined questions to gather individual perceptions regarding the 3 interventional conditions during a conversation in noise in the laboratory. The data collected from this questionnaire are scores on a rating scale from "0" (worst) to "5" (best) in increments of 1.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study startAug 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
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 sound changing principle in a randomized order.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
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
- NCT06992310
- Sponsor's protocol ID
- SRF-30177
- Status last verified
- May 2025
- First submitted
- 27 May 2025
- Last updated
- 3 Jun 2025
- 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 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Functional Effect of Different Hearing Aid Noise Reduction Algorithms in an Ecologically Valid Conversational Situation
- ClinicalTrials.gov ID
- NCT06992310
- Acronym / sponsor ID
- SRF-30177
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Sebastian GriepentrogIndustry (pharma, biotech, devices)
- Study start
- Aug 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 28 May 2025 (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.
A methodical evaluation of sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. These sound changing principles are enabled by respective hearing instrument technologies and hearing instrument algorithms. The aim of the study is to investigate and asses strength and weaknesses of these novel sound changing principles in terms of hearing performance 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 sound changing principle in a randomized order.
| Arm | Type | Receives |
|---|---|---|
| Hearing aid standard NR_1 | Active comparator | Device: Hearing Aid with standard noise reduction (NR_1)Hearing Aid with standard noise reduction (NR) serves as reference condition |
| Hearing Aid with NR_2 | Experimental | Device: Hearing Aid with NR_2NR_2: Noise reduction principle 2 |
| Hearing Aid with NR_3 | Experimental | Device: Hearing Aid with NR_3NR_3: Noise reduction principle 3 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Good written and spoken German language skills
- No suffering from any speech disorders
- Experienced hearing aid user (min. 6 months)
- Ability to stand and walk during the experiment
- Ability to fill in a questionnaire conscientiously
Key exclusion criteria (13 listed)
- Contraindications to the medical device
- Unaidable hearing loss in one or both ears
- Acute tinnitus (in either one ear and occurrence for less than 3 months)
- Anatomical deformity of one or both ears
- Single-sided deafness
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 |
|---|---|---|
| Hearing Aid with standard noise reduction (NR_1)Each participant will be fitted with the 3 different noise reduction (sound changing) principles on the same hearing aid, saved to 3 manual programs (ensures exact same hearing loss compensation for each intervention). Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The active comparator condition is the state of the art Noise Reduction principle to mimic the natural directivity of the outer ear. | Device | Hearing aid standard NR_1 |
| Hearing Aid with NR_2Each participant will be fitted with the 3 different noise reduction (sound changing) principles on the same hearing aid, saved to 3 manual programs (ensures exact same hearing loss compensation for each intervention). Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of noise suppression and good speech quality. | Device | Hearing Aid with NR_2 |
| Hearing Aid with NR_3Each participant will be fitted with the 3 different noise reduction (sound changing) principles on the same hearing aid, saved to 3 manual programs (ensures exact same hearing loss compensation for each intervention). Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of noise suppression and good speech quality. | Device | Hearing Aid with NR_3 |
Primary outcome
Own Voice Level
Time frame: 3 weeks
Changes to the participants' own voice level (RMS in dB) during a conversation in noise in the laboratory will be recorded in each interventional condition.
2 secondary outcomes
Interpersonal distance
Time frame: 3 weeks
Qualitative interview form
Time frame: 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- 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.
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 Hearing Aid with standard noise reduction (NR_1), Hearing Aid with NR_2 and Hearing Aid with NR_3 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 11 inclusion and 13 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: opening soon, as of the sponsor's last update on 3 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sebastian Griepentrog (004158928 ext. 8676, sebastian.griepentrog@sonova.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Own Voice Level (time frame: 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 3 Jun 2025.