Frequency LoweringNCT05733169
Pre-calculation for Frequency Lowering With Hearing Devices
A study testing Frequency lowering intervention and Frequency lowering reference in people with Frequency Lowering, run by Sonova AG at 1 site in Switzerland.
Trial summary
Perceptual evaluation of the parametrization and pre-calculation of frequency lowering requires the participation of subjects with hearing loss. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frequency Lowering
- What is being tested?
- Frequency lowering intervention and Frequency lowering reference
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Jan 2023to 4 Apr 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Experienced hearing aid user (minimum use duration 1 year)
- Adult (minimum age: 18 years),
- Experience with frequency lowering,
- Hearing thresholds with N5-N7, S1, S2, S3 hearing loss
- Symmetrical hearing loss (difference between ears <= 10 dB for 1kHz-6kHz) ,
- Sensorineural hearing loss,
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- Air Conduction - bone conduction gap <= 10 dB,
- Written and spoken German,
- Ability to understand instruction,
- Ability to describe listening experiences,
- Ability to attend to the appointments,
- Ability to fill in a questionnaire conscientiously
- Healthy outer ear (without previous surgical procedures)
- Hearing loss within the fitting ranges of the investigational product,
- Informed consent as documented by signature.
Who cannot join
- Clinical contraindications deformity of the ear (closed ear canal
- or absence of pinna),
- Not willing to wear the hearing aid,
- Fluctuating hearing that could influence the results,
- Contraindications to the MD in this study, e.g. known hypersen-sitivity or allergy to the investigational product,
- Limited mobility and not in the position to attend all appoint-ments,
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- Limited ability to describe listening impressions/experiences and the use of the hearing aid,
- Inability to produce a reliable hearing test result,
- Massively limited dexterity,
- Known psychological problems,
- Known central hearing disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Perceptual evaluation of the parametrization and pre-calculation of frequency lowering requires the participation of subjects with hearing loss.
- Conditions
- Frequency Lowering
- Being tested
- Frequency lowering intervention, Frequency lowering reference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frequency lowering interventionOther
Also called Intervention condition
Modified parametrization of the current frequency lowering parametrization.
Frequency lowering referenceOther
Also called Reference condition
Current frequency lowering parametrization
| Study group | Role | What they receive |
|---|---|---|
| Hearing impaired group | Experimental | The hearing impaired group will compare the reference condition with the intervention condition. Receives: Other: Frequency lowering intervention; Other: Frequency lowering reference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of sound quality and audibility of high-frequency sounds for hearing-impaired subjects with the new parametrization compared to the current implementation of the parametrization.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start16 Jan 2023
- Primary completion4 Apr 2023
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frequency LoweringStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733169
- Sponsor's protocol ID
- 5937
- Status last verified
- Aug 2023
- First submitted
- 27 Jan 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-calculation for Frequency Lowering With Hearing Devices
- ClinicalTrials.gov ID
- NCT05733169
- Acronym / sponsor ID
- 5937
- Conditions
- Frequency Lowering
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 17 Feb 2023 (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.
Perceptual evaluation of the parametrization and pre-calculation of frequency lowering requires the participation of subjects with hearing loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hearing impaired group | Experimental | Other: Frequency lowering intervention, Other: Frequency lowering referenceThe hearing impaired group will compare the reference condition with the intervention condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Experienced hearing aid user (minimum use duration 1 year)
- Adult (minimum age: 18 years),
- Experience with frequency lowering,
- Hearing thresholds with N5-N7, S1, S2, S3 hearing loss
- Symmetrical hearing loss (difference between ears <= 10 dB for 1kHz-6kHz) ,
Key exclusion criteria (11 listed)
- Clinical contraindications deformity of the ear (closed ear canal
- or absence of pinna),
- Not willing to wear the hearing aid,
- Fluctuating hearing that could influence the results,
- Contraindications to the MD in this study, e.g. known hypersen-sitivity or allergy to the investigational product,
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 |
|---|---|---|
| Frequency lowering interventionAlso: Intervention conditionModified parametrization of the current frequency lowering parametrization. | Other | Hearing impaired group |
| Frequency lowering referenceAlso: Reference conditionCurrent frequency lowering parametrization | Other | Hearing impaired group |
Primary outcome
Measurement of sound quality and audibility of high-frequency sounds for hearing-impaired subjects with the new parametrization compared to the current implementation of the parametrization.
Time frame: 6 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 30 Aug 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frequency lowering intervention and Frequency lowering reference in people with Frequency Lowering, run by Sonova AG 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 15 inclusion and 11 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 30 Aug 2023. 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 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?
Measurement of sound quality and audibility of high-frequency sounds for hearing-impaired subjects with the new parametrization compared to the current implementation of the parametrization. (time frame: 6 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 30 Aug 2023.