Hearing LossNCT02895477
Quest Sound Recover (SR2) vs. Venture SR2
A study testing hearing aid in people with Hearing Loss, run by Sonova AG at 1 site in Switzerland.
Trial summary
Goal of this study is to determine the benefit of an improved feature on a new hearing aid platform. To investigate the improvements of this feature is compared on a new and older hearing aid platform. The obtained results will be used for future improvement for this feature. 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2016to 20 Jan 2017
- 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
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Ability to fill in a question conscientious
- Healthy outer ear (w/o previous surgical procedures)
- Sensorineural symmetric hearing loss (HL)
- N4 to N7 (degree of HL)
Who cannot join
- Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product,
- Limited mobility and not in the position to attend weekly appointments
- Limited ability to describe listening impressions/experiences and the use of the hearing aid
- Inability to produce a reliable hearing test result when pure tone audiometry is attempted by the audiologist
- Massively limited dexterity
- Known Psychological problems
- Central hearing problems
Trial locations and contacts
1 site in 1 country.
About this study
Goal of this study is to determine the benefit of an improved feature on a new hearing aid platform.
To investigate the improvements of this feature is compared on a new and older hearing aid platform. The obtained results will be used for future improvement for this feature. This feature should improve the speech understanding and speech recognition of the hearing aid user.
- Conditions
- Hearing Loss
- Being tested
- hearing aid
- 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 aidDevice
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Hearing aid Receives: Device: hearing aid |
| Test group | Experimental | Hearing aid Receives: Device: hearing aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional gain
Functional gain is to measure the aided threshold (in dB hearing level [HL]) in free field via loudspeaker.
Measured: after 2 weeks
Phoneme Perception Test
Change of Detection thresholds after 4 weeks hearing instrument wearing time
Measured: after 2
Functional gain
Functional gain is to measure the aided threshold (in dB hearing level [HL]) in free field via loudspeaker.
Measured: after 8 weeks
Phoneme Perception Test
Change of detection thresholds after 4 weeks hearing instrument wearing time
Measured: after 8 weeks
Secondary outcomes (2)
sound quality ratings
Measured: after 6 and 12 weeks
questionnaires
Measured: after 2, 6, 8 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2016
- Study completion20 Jan 2017
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 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
- NCT02895477
- Sponsor's protocol ID
- Sonova2016_10
- Status last verified
- Jan 2017
- First submitted
- 29 Aug 2016
- Last updated
- 30 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quest Sound Recover (SR2) vs. Venture SR2
- ClinicalTrials.gov ID
- NCT02895477
- Acronym / sponsor ID
- Sonova2016_10
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- 20 Jan 2017 (actual)
- First posted
- 9 Sep 2016 (estimated)
- 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.
Goal of this study is to determine the benefit of an improved feature on a new hearing aid platform.
To investigate the improvements of this feature is compared on a new and older hearing aid platform. The obtained results will be used for future improvement for this feature. This feature should improve the speech understanding and speech recognition of the hearing aid user.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: hearing aidHearing aid |
| Test group | Experimental | Device: hearing aidHearing aid |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Ability to fill in a question conscientious
- Healthy outer ear (w/o previous surgical procedures)
- Sensorineural symmetric hearing loss (HL)
- N4 to N7 (degree of HL)
Key exclusion criteria (7 listed)
- Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product,
- Limited mobility and not in the position to attend weekly appointments
- Limited ability to describe listening impressions/experiences and the use of the hearing aid
- Inability to produce a reliable hearing test result when pure tone audiometry is attempted by the audiologist
- Massively limited dexterity
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 | Device | Intervention group, Test group |
Primary outcome
Functional gain
Time frame: after 2 weeks
Functional gain is to measure the aided threshold (in dB hearing level [HL]) in free field via loudspeaker.
Phoneme Perception Test
Time frame: after 2
Change of Detection thresholds after 4 weeks hearing instrument wearing time
Functional gain
Time frame: after 8 weeks
Functional gain is to measure the aided threshold (in dB hearing level [HL]) in free field via loudspeaker.
Phoneme Perception Test
Time frame: after 8 weeks
Change of detection thresholds after 4 weeks hearing instrument wearing time
2 secondary outcomes
sound quality ratings
Time frame: after 6 and 12 weeks
questionnaires
Time frame: after 2, 6, 8 and 12 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 Jan 2017.
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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 hearing aid in people with Hearing Loss, 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 5 inclusion and 7 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 Jan 2017. 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?
Functional gain (time frame: after 2 weeks). The study lists 4 primary outcomes in all. 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 Jan 2017.