Hearing Loss, Bilateral or UnilateralNCT02298452
Performance of a Hearing Aid Platform Including Different Styles of Hearing Aids
A study testing Hearing aid. in people with Hearing Loss, Bilateral or Unilateral, run by Phonak AG, Switzerland at 1 site in Switzerland.
Trial summary
The reason for this study is to evaluate a new hearing aid product generation replacing the one on the market. The goal is to evaluate the audiological performance, usability as well as features and functions. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hearing Loss, Bilateral or Unilateral
- 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
- 253 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2013to Sep 2015
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all kinds of hearing loss (sensorineural, conductive, combined)
- all kinds of hearing loss (flat, sloping) which are in the fitting range of the hearing aids
- mother tongue (swiss) german
Who cannot join
- Subjects
- with a reduced mobility unable to attend weekly study appointments
- without access to a number of different hearing situations
- with strongly reduced ability to describe auditory impressions and the usage of the hearing aids
- which are uncooperative so that it is not possible to record a valid pure tone audiogram
- with a strongly reduced dexterity
- with psychological problems
- central hearing disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Structured Post Market Clinical Follow-up (PMCF) to Evaluate the Quality of a New Hearing Aid Product Generation.
The reason for this study is to evaluate a new hearing aid product generation replacing the one on the market. The goal is to evaluate the audiological performance, usability as well as features and functions.
Read the detailed description
This is a controlled, single blinded comparative study which is conducted monocentric at Phonak Headquarters in Staefa. The focus is to compare a new hearing aid product generation with the one on the market as well as with competitor devices regarding the audiological performance, usability as well as features and functions with the aid of 382 mild to profound hearing impaired subjects (18-90 yrs). The subjects, all of them native (Swiss) German speakers, individually conduct a number of laboratory standard tests and home trials (questionnaires) during nine weeks including weekly appointments of 2 hours.
- Conditions
- Hearing Loss, Bilateral or Unilateral
- 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 aid.Device
The hearing aid will be fitted to the individual hearing loss of the subject.
| Study group | Role | What they receive |
|---|---|---|
| Hearing aid | Other | 172 subjects with a mild hearing loss. 140 subjects with a moderate hearing loss. 70 subjects with a severe/ profound hearing loss. Receives: Device: Hearing aid. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of speech intelligibility between devices based on Quest platform and Venture platform for different hearing aid styles
For the objective measurements in laboratory situation, both a standard German speech sentence test in noise (SRT in dB) and a standard German monosyllable word test in quiet (speech discrimination in percent) are used to compare the speech intelligibility for both platforms. The results of the Venture platform of both tests should be at least the same or better than with the Quest platform.
Measured: 3 years
Secondary outcomes (3)
Subjective ratings of speech intelligibility during home trials
For the subjective rating of speech intelligibility, questionnaires are used to compare the current platform Quest with the new platform Venture. The subjective impressions are rated by rating scales (e.g. Speech intelligibility in quiet: everything - most - half - little - nothing).
Measured: 3 years
Subjective ratings of sound quality during home trials
For the subjective rating of sound quality, questionnaires are used to compare the current platform Quest with the new platform Venture. The subjective impressions are rated by rating scales (e.g. Sound quality for speech in quiet: good - dull - sharp - thin - echo - scratchy - unclear - noisy).
Measured: 3 years
Subjective ratings of usability during home trials
For the subjective rating of usability, questionnaires are used to compare the current platform Quest with the new platform Venture . The subjective impressions are rated by rating scales (e.g. Rating of the opening and closing of the battery door: very easy - easy - neither - difficult - very difficult).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startMay 2013
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, Bilateral or UnilateralStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phonak AG, Switzerland
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Simone Ebbing, B. Sc., Principal investigator, Phonak AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298452
- Sponsor's protocol ID
- KEK 2013-0144
- Status last verified
- May 2016
- First submitted
- 17 Nov 2014
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structured Post Market Clinical Follow-up (PMCF) to Evaluate the Quality of a New Hearing Aid Product Generation.
- ClinicalTrials.gov ID
- NCT02298452
- Acronym / sponsor ID
- KEK 2013-0144
- Conditions
- Hearing Loss, Bilateral or Unilateral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Phonak AG, SwitzerlandIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 24 Nov 2014 (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.
The reason for this study is to evaluate a new hearing aid product generation replacing the one on the market. The goal is to evaluate the audiological performance, usability as well as features and functions.
Detailed description
This is a controlled, single blinded comparative study which is conducted monocentric at Phonak Headquarters in Staefa. The focus is to compare a new hearing aid product generation with the one on the market as well as with competitor devices regarding the audiological performance, usability as well as features and functions with the aid of 382 mild to profound hearing impaired subjects (18-90 yrs). The subjects, all of them native (Swiss) German speakers, individually conduct a number of laboratory standard tests and home trials (questionnaires) during nine weeks including weekly appointments of 2 hours.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hearing aid | Other | Device: Hearing aid.172 subjects with a mild hearing loss. 140 subjects with a moderate hearing loss. 70 subjects with a severe/ profound hearing loss. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- all kinds of hearing loss (sensorineural, conductive, combined)
- all kinds of hearing loss (flat, sloping) which are in the fitting range of the hearing aids
- mother tongue (swiss) german
Key exclusion criteria (8 listed)
- Subjects
- with a reduced mobility unable to attend weekly study appointments
- without access to a number of different hearing situations
- with strongly reduced ability to describe auditory impressions and the usage of the hearing aids
- which are uncooperative so that it is not possible to record a valid pure tone audiogram
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.The hearing aid will be fitted to the individual hearing loss of the subject. | Device | Hearing aid |
Primary outcome
Difference of speech intelligibility between devices based on Quest platform and Venture platform for different hearing aid styles
Time frame: 3 years
For the objective measurements in laboratory situation, both a standard German speech sentence test in noise (SRT in dB) and a standard German monosyllable word test in quiet (speech discrimination in percent) are used to compare the speech intelligibility for both platforms. The results of the Venture platform of both tests should be at least the same or better than with the Quest platform.
3 secondary outcomes
Subjective ratings of speech intelligibility during home trials
Time frame: 3 years
Subjective ratings of sound quality during home trials
Time frame: 3 years
Subjective ratings of usability during home trials
Time frame: 3 years
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 3 May 2016.
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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.
Simone Ebbing, B. Sc. principal investigator
Phonak 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. in people with Hearing Loss, Bilateral or Unilateral, 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 3 inclusion and 8 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 3 May 2016. 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?
Difference of speech intelligibility between devices based on Quest platform and Venture platform for different hearing aid styles (time frame: 3 years). 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 May 2016.