Validation StudiesNCT02555462
Real-Ear Measurement (REM) and Test Box System Integration Into Fitting Software
A study testing Real-Ear Measurement system integrated in hearing aid fitting software in people with Validation Studies, run by Phonak AG, Switzerland at 1 site in Switzerland.
Trial summary
Integration of the REM-verification within the fitting workflow will enable the hearing care professional to easily run real ear measurements. The purpose of the two study parts is to prove that an integrated cooperative system, consisting of fitting software and measurement system, matches desired responses for… Read more about this study
- Who is it for?
- Ages 16 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Validation Studies
- What is being tested?
- Real-Ear Measurement system integrated in hearing aid fitting software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2015to Dec 2016
- 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 16 to 67 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Clean and healthy ear canal, eardrum and pinna
- Ability to keep current position (of head and body) during a period of about 5 minutes while seated.
Who cannot join
- Ear infections
- Ear wax in the ear
- Hyperacusis
- Pacemaker
- Tremor
- Disability to keep position.
Trial locations and contacts
1 site in 1 country.
About this study
Integration of the REM-verification within the fitting workflow will enable the hearing care professional to easily run real ear measurements. The purpose of the two study parts is to prove that an integrated cooperative system, consisting of fitting software and measurement system, matches desired responses for certain stimuli faster, more reliably and more precisely at the ear drums of hearing instrument wearers than current best practice processes.
- Conditions
- Validation Studies
- Being tested
- Real-Ear Measurement system integrated in hearing aid fitting software
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-Ear Measurement system integrated in hearing aid fitting softwareDevice
The subjects individual response of the ear canal gets measured with the help of a probe tube and a following hearing aid fitting.
| Study group | Role | What they receive |
|---|---|---|
| Real-Ear Measurement | Experimental | The study arm goes through a comparative test run followed by a comparative hearing aid fitting. Receives: Device: Real-Ear Measurement system integrated in hearing aid fitting software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance (mm) from probe tube to eardrum measurement
Precise of the Probe Tube placement
Measured: 1 month
Procedure time (min) of fitting workflow including Real Ear measurement
In addition to the outcome measurement "time" (in minutes) further outcome measurements can be obtained due to the performed real ear measurement procedure itself.
Data that give information pertaining to test reliability (in dB) and precision of hearing aid fitting (in dB).
Measured: 2 month
Secondary outcomes (2)
Subjective rating of unpleasantness (0 = not unpleasant at all, 10 = very unpleasant)
Pleasantness during the probe tube placement
Measured: 1 month
Questionnaire about perceived annoyance
Perceived annoyance of the hearing care professional and the test subject measured with a questionnaire including rating scales for stessful and boring.
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Validation StudiesStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 205 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phonak AG, Switzerland
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555462
- Sponsor's protocol ID
- KEK-ZH-NR.2015-0099
- Status last verified
- Apr 2017
- First submitted
- 14 Sep 2015
- Last updated
- 4 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Ear Measurement (REM) and Test Box System Integration Into Fitting Software
- ClinicalTrials.gov ID
- NCT02555462
- Acronym / sponsor ID
- KEK-ZH-NR.2015-0099
- Conditions
- Validation Studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (estimated)
- Lead sponsor
- Phonak AG, SwitzerlandIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 21 Sep 2015 (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.
Integration of the REM-verification within the fitting workflow will enable the hearing care professional to easily run real ear measurements. The purpose of the two study parts is to prove that an integrated cooperative system, consisting of fitting software and measurement system, matches desired responses for certain stimuli faster, more reliably and more precisely at the ear drums of hearing instrument wearers than current best practice processes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Real-Ear Measurement | Experimental | Device: Real-Ear Measurement system integrated in hearing aid fitting softwareThe study arm goes through a comparative test run followed by a comparative hearing aid fitting. |
Who may qualify
- Ages
- 16 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clean and healthy ear canal, eardrum and pinna
- Ability to keep current position (of head and body) during a period of about 5 minutes while seated.
Key exclusion criteria (6 listed)
- Ear infections
- Ear wax in the ear
- Hyperacusis
- Pacemaker
- Tremor
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 |
|---|---|---|
| Real-Ear Measurement system integrated in hearing aid fitting softwareThe subjects individual response of the ear canal gets measured with the help of a probe tube and a following hearing aid fitting. | Device | Real-Ear Measurement |
Primary outcome
Distance (mm) from probe tube to eardrum measurement
Time frame: 1 month
Precise of the Probe Tube placement
Procedure time (min) of fitting workflow including Real Ear measurement
Time frame: 2 month
In addition to the outcome measurement "time" (in minutes) further outcome measurements can be obtained due to the performed real ear measurement procedure itself. Data that give information pertaining to test reliability (in dB) and precision of hearing aid fitting (in dB).
2 secondary outcomes
Subjective rating of unpleasantness (0 = not unpleasant at all, 10 = very unpleasant)
Time frame: 1 month
Questionnaire about perceived annoyance
Time frame: 2 month
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 4 Apr 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 Real-Ear Measurement system integrated in hearing aid fitting software in people with Validation Studies, run by Phonak AG, Switzerland 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 2 inclusion and 6 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 4 Apr 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?
Distance (mm) from probe tube to eardrum measurement (time frame: 1 month). The study lists 2 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 4 Apr 2017.