Hearing LossNCT05582408
Evaluation of Novel Noise Reduction Principles in Hearing Instruments
A study testing Measures of Standard Noise Reduction NR1, Measures of Noise Reduction Principle NR2 and Measure of Noise Reduction Principle NR3 in people with Hearing Loss, run by Sonova AG at 1 site in Germany.
Trial summary
In the study, the speech intelligibility in noise (Outcome) between a novel noise reduction algorithm (Intervention) versus the standard noise reduction (Comparator) will be tested in adults with a N3-N4 hearing loss (Population) using streamed signals via hearing aids. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Measures of Standard Noise Reduction NR1, Measures of Noise Reduction Principle NR2 and Measure of Noise Reduction Principle NR3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteGermany
- Study dates
- 12 Sep 2022to 1 Nov 2022
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum age for men: 18 years, minimum age for wom-en: 64 years, hearing aid users,
- Written and spoken German,
- Hearing loss range: N3-N4 Hearing loss (sensorineural)
- Healthy outer ear,
- Ability to understand and follow the instruction of the in-vestigator
- Informed consent as documented by signature.
Who cannot join
- Clinical contraindications 1) hearing loss is not within the fitting range of the hearing aid, 2) acute tinnitus, 3) de-formity of the ear (closed ear canal or absence of pinna), and 4) neural hearing loss i.e., retro-cochlear pathologies such as absent / non-viable auditory nerve
- Pregnant or breastfeeding women
- Age >85 years
- known hypersensitivity or allergy,
- limited mobility and not able to attend the appointments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Novel Noise Reduction Principles in Hearing Instruments to Determine Their Applicability.
In the study, the speech intelligibility in noise (Outcome) between a novel noise reduction algorithm (Intervention) versus the standard noise reduction (Comparator) will be tested in adults with a N3-N4 hearing loss (Population) using streamed signals via hearing aids.
- Conditions
- Hearing Loss
- Being tested
- Measures of Standard Noise Reduction NR1, Measures of Noise Reduction Principle NR2, Measure of Noise Reduction Principle NR3
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measures of Standard Noise Reduction NR1Device
Each participant will be fitted with the Standard Noise Reduction (NR1)
Measures of Noise Reduction Principle NR2Device
Each participant will be fitted with the novel Noise Reduction principle NR2 on the same hearing aid
Measure of Noise Reduction Principle NR3Device
Each participant will be fitted with the novel Noise Reduction principle NR3 on the same hearing aid
| Study group | Role | What they receive |
|---|---|---|
| Hearing Aid Standard NR1 | Active comparator | Hearing Aid with standard Noise Reduction (NR1) serves as reference condition. Receives: Device: Measures of Standard Noise Reduction NR1 |
| Novel Noise reduction principles | Experimental | Noise Reduction Principle NR2 and NR3. Receives: Device: Measures of Noise Reduction Principle NR2; Device: Measure of Noise Reduction Principle NR3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in speech reception thresholds (SRTs) in noise between novel noise reduction algorithm (NR2) and the standard noise reduction (NR1; Comparator)
SRTs are measured with the OLSA test.
Measured: 4 weeks
Secondary outcomes (2)
Evaluation whether the novel noise reduction algorithm (NR3) provides different SRTs in noisy situation with speech from front compared to the current implemented "standard noise reduction" (NR1; Comparator)
SRTs are measured with the OLSA test.
Measured: 4 weeks
Evaluation of subjectively different sound quality attributes/dimensions of the novel noise reduction algorithms versus standard noise reduction (Comparator)
The sound quality ratings will be assessed with the aid of a Multi-Stimulus Test.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start12 Sep 2022
- Primary completion25 Oct 2022
- Study completion1 Nov 2022
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
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marlene Zippel, Study director, Sonova AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582408
- Sponsor's protocol ID
- SRF-382
- Status last verified
- Sep 2022
- First submitted
- 12 Oct 2022
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Novel Noise Reduction Principles in Hearing Instruments to Determine Their Applicability.
- ClinicalTrials.gov ID
- NCT05582408
- Acronym / sponsor ID
- SRF-382
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 17 Oct 2022 (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.
In the study, the speech intelligibility in noise (Outcome) between a novel noise reduction algorithm (Intervention) versus the standard noise reduction (Comparator) will be tested in adults with a N3-N4 hearing loss (Population) using streamed signals via hearing aids.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hearing Aid Standard NR1 | Active comparator | Device: Measures of Standard Noise Reduction NR1Hearing Aid with standard Noise Reduction (NR1) serves as reference condition. |
| Novel Noise reduction principles | Experimental | Device: Measures of Noise Reduction Principle NR2, Device: Measure of Noise Reduction Principle NR3Noise Reduction Principle NR2 and NR3. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Minimum age for men: 18 years, minimum age for wom-en: 64 years, hearing aid users,
- Written and spoken German,
- Hearing loss range: N3-N4 Hearing loss (sensorineural)
- Healthy outer ear,
- Ability to understand and follow the instruction of the in-vestigator
Key exclusion criteria (5 listed)
- Clinical contraindications 1) hearing loss is not within the fitting range of the hearing aid, 2) acute tinnitus, 3) de-formity of the ear (closed ear canal or absence of pinna), and 4) neural hearing loss i.e., retro-cochlear pathologies such as absent / non-viable auditory nerve
- Pregnant or breastfeeding women
- Age >85 years
- known hypersensitivity or allergy,
- limited mobility and not able to attend the appointments
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 |
|---|---|---|
| Measures of Standard Noise Reduction NR1Each participant will be fitted with the Standard Noise Reduction (NR1) | Device | Hearing Aid Standard NR1 |
| Measures of Noise Reduction Principle NR2Each participant will be fitted with the novel Noise Reduction principle NR2 on the same hearing aid | Device | Novel Noise reduction principles |
| Measure of Noise Reduction Principle NR3Each participant will be fitted with the novel Noise Reduction principle NR3 on the same hearing aid | Device | Novel Noise reduction principles |
Primary outcome
Difference in speech reception thresholds (SRTs) in noise between novel noise reduction algorithm (NR2) and the standard noise reduction (NR1; Comparator)
Time frame: 4 weeks
SRTs are measured with the OLSA test.
2 secondary outcomes
Evaluation whether the novel noise reduction algorithm (NR3) provides different SRTs in noisy situation with speech from front compared to the current implemented "standard noise reduction" (NR1; Comparator)
Time frame: 4 weeks
Evaluation of subjectively different sound quality attributes/dimensions of the novel noise reduction algorithms versus standard noise reduction (Comparator)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
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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.
Marlene Zippel study director
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 Measures of Standard Noise Reduction NR1, Measures of Noise Reduction Principle NR2 and Measure of Noise Reduction Principle NR3 in people with Hearing Loss, run by Sonova AG at 1 site in Germany.
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 5 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: finished, as of the sponsor's last update on 17 Nov 2022. 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 Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference in speech reception thresholds (SRTs) in noise between novel noise reduction algorithm (NR2) and the standard noise reduction (NR1; Comparator) (time frame: 4 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 17 Nov 2022.