Hearing Loss, Bilateral or UnilateralCPSNCT02545569
Evaluation of New Custom Made Hearing Product Technology and Shell Modification
A study testing hearing aid (MD class IIa) - ITE, BTE, RIC in people with Hearing Loss, Bilateral or Unilateral, run by Phonak AG, Switzerland at 1 site in Switzerland.
Trial summary
The purpose of this evaluation is to receive the greatest benefit of new custom made hearing product technology and shell modification for the end customer and to continual improve the custom made hearing products. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Bilateral or Unilateral
- What is being tested?
- hearing aid (MD class IIa) - ITE, BTE, RIC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Jan 2020to Dec 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Only adult participants between 18 and 99 years
- lnformed Consent as documented by signature (Appendix lnformed Consent Form)
- Ability to fill in a questionnaire conscientious
- Healthy outer ear (w/o previous surgical procedures)
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
- lnability to produce a reliable hearing test result when pure tone audiometry is attempted by the audiologist
- Massively limited dexterity
- Psychological problems
- Central hearing problems
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Sonova AG
Stäfa, Canton of Zurich, 8712
Jana-Kosima Schwarzlos, 0041 58 928 0101, JanaKosima.Schwarzlos@sonova.com
About this study
The purpose of this evaluation is to receive the greatest benefit of new custom made hearing product technology and shell modification for the end customer and to continual improve the custom made hearing products.
Read the detailed description
This is a controlled, single blinded comparative study which is conducted monocentric at Phonak Headquarters in Staefa.
The purpose of the studies is to evaluate the strengths and weaknesses of new custom product development in comparison to existing/old products. The results should promote the custom product development, to provide a maximum of benefit and wearing comfort to the hearing aid user.
- Conditions
- Hearing Loss, Bilateral or Unilateral
- Being tested
- hearing aid (MD class IIa) - ITE, BTE, RIC
- 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 (MD class IIa) - ITE, BTE, RICDevice
Also called hearing accessory (MD class I) - DM systems, FM systems, remote control
Hearing aid means any wearable instrument or device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing.
| Study group | Role | What they receive |
|---|---|---|
| Hearing Device Type A | Active comparator | In the ear (ITE) hearing aid, 1-3 weeks wearing Receives: Device: hearing aid (MD class IIa) - ITE, BTE, RIC |
| Hearing Device Type B | Experimental | In the ear (ITE) hearing aid, 1-3 weeks wearing Receives: Device: hearing aid (MD class IIa) - ITE, BTE, RIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective measurement of speech intelligibility related to the intervention.
SNR (speech to noise ratio) in decibel.
Measured: 5 years
Objective measurement of the transfer function related to the intervention.
REM (real ear measurement) in decibel.
Measured: 5 years
Objective measurement from the position of the outer ear related to the test subject.
Measurement in degree.
Measured: 5 years
Objective measurement from the size of the outer ear related to the test subject.
Measurement in micron.
Measured: 5 years
Objective measurement of humidity in the ear canal related to the test subject and the intervention.
Measurement in percent.
Measured: 5 years
Objective measurement of temperature in the ear canal related to the test subject and the intervention.
Measurement in degree centigrade.
Measured: 5 years
Secondary outcomes (1)
Subjective rating of the intervention via questionnaire.
Ordinal scale
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study start6 Jan 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phonak AG, Switzerland
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jana-Kosima Schwarzlos, B.Sc., Principal investigator, Switzerland, Sonova AG, CH-8712 Staefa, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545569
- Sponsor's protocol ID
- KEK-ZH-Nr. 2014-0459
- Acronym
- CPS
- Status last verified
- Aug 2019
- First submitted
- 19 Aug 2015
- Last updated
- 30 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of New Custom Made Hearing Product Technology and Shell Modification
- ClinicalTrials.gov ID
- NCT02545569
- Acronym / sponsor ID
- CPS / KEK-ZH-Nr. 2014-0459
- Conditions
- Hearing Loss, Bilateral or Unilateral
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Phonak AG, SwitzerlandIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 10 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.
The purpose of this evaluation is to receive the greatest benefit of new custom made hearing product technology and shell modification for the end customer and to continual improve the custom made hearing products.
Detailed description
This is a controlled, single blinded comparative study which is conducted monocentric at Phonak Headquarters in Staefa.
The purpose of the studies is to evaluate the strengths and weaknesses of new custom product development in comparison to existing/old products. The results should promote the custom product development, to provide a maximum of benefit and wearing comfort to the hearing aid user.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hearing Device Type A | Active comparator | Device: hearing aid (MD class IIa) - ITE, BTE, RICIn the ear (ITE) hearing aid, 1-3 weeks wearing |
| Hearing Device Type B | Experimental | Device: hearing aid (MD class IIa) - ITE, BTE, RICIn the ear (ITE) hearing aid, 1-3 weeks wearing |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Only adult participants between 18 and 99 years
- lnformed Consent as documented by signature (Appendix lnformed Consent Form)
- Ability to fill in a questionnaire conscientious
- Healthy outer ear (w/o previous surgical procedures)
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
- lnability 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 (MD class IIa) - ITE, BTE, RICAlso: hearing accessory (MD class I) - DM systems, FM systems, remote controlHearing aid means any wearable instrument or device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing. | Device | Hearing Device Type A, Hearing Device Type B |
Primary outcome
Objective measurement of speech intelligibility related to the intervention.
Time frame: 5 years
SNR (speech to noise ratio) in decibel.
Objective measurement of the transfer function related to the intervention.
Time frame: 5 years
REM (real ear measurement) in decibel.
Objective measurement from the position of the outer ear related to the test subject.
Time frame: 5 years
Measurement in degree.
Objective measurement from the size of the outer ear related to the test subject.
Time frame: 5 years
Measurement in micron.
Objective measurement of humidity in the ear canal related to the test subject and the intervention.
Time frame: 5 years
Measurement in percent.
Objective measurement of temperature in the ear canal related to the test subject and the intervention.
Time frame: 5 years
Measurement in degree centigrade.
1 secondary outcome
Subjective rating of the intervention via questionnaire.
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
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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.
Jana-Kosima Schwarzlos, B.Sc. principal investigator
Switzerland, Sonova AG, CH-8712 Staefa, Zurich
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 (MD class IIa) - ITE, BTE, RIC 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 4 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: status not confirmed, as of the sponsor's last update on 30 Aug 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jana-Kosima Schwarzlos, B.Sc. (+41 58 928 0101, JanaKosima.Schwarzlos@sonova.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective measurement of speech intelligibility related to the intervention. (time frame: 5 years). The study lists 6 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 Aug 2019.