Ear AnatomyNCT03303183
Benchmark Ear Impression Techniques
A study testing Standard Impression technique and Direct Ear Scanner in people with Ear Anatomy, run by Sonova AG at 1 site in Switzerland.
Trial summary
The purpose of this study is to determine the scan quality of the direct ear scanner concerning consistency, accuracy and reliability and to compare the data to common silicone ear impressions by benchmarking the outcome of each impression technique on custom product dummies on participants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ear Anatomy
- What is being tested?
- Standard Impression technique and Direct Ear Scanner
- 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
- 23 Oct 2017to 15 Dec 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Only adult participants ≥ 18 years
- Informed consent form as documented by signature
- Ability to fill in a questionnaire conscientious
- Healthy outer ear (Pinna and ear canal, 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
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the scan quality of the direct ear scanner concerning consistency, accuracy and reliability and to compare the data to common silicone ear impressions by benchmarking the outcome of each impression technique on custom product dummies on participants.
Read the detailed description
Today's standard for ear impression techniques is the impression taking process with silicone impression material. To use the silicone impression for a hearing aid manufacturing process the geometry of the impression is needed. Modern processes scan the silicone ear impression with specific scanners. Afterwards the digitalized ear impression is uploaded in the modeling software for further proceed. A new ear impression technique is now provided with the direct ear scanner technology. The direct ear scanner can create a digital scan of the outer ear and ear canal. The scan than can directly transferred to the modeling software. The research question of this study is to determine the scan quality of the direct ear scanner concerning consistency, accuracy and reliability and to compare the data to common silicone ear impressions.
- Conditions
- Ear Anatomy
- Being tested
- Standard Impression technique, Direct Ear Scanner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Impression techniqueDevice
Silicone impression technique
Direct Ear ScannerDevice
Direct Ear Scanner to scan the ear anatomy
| Study group | Role | What they receive |
|---|---|---|
| Direct Ear Scanner | Active comparator | Digitale impression via direct ear scanner Receives: Device: Direct Ear Scanner |
| Silicone Ear impression | Active comparator | Impression via silicone Receives: Device: Standard Impression technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deviation of Direct ear scanner compared to silicone impressions
Deviation of the scan of Direct ear scanner compared to silicone impressions with two viscosities [mm]
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start23 Oct 2017
- Primary completion15 Dec 2018
- Study completion15 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ear AnatomyStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 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
- NCT03303183
- Sponsor's protocol ID
- KEK-ZH Nr.2014-0326
- Status last verified
- Nov 2019
- First submitted
- 2 Oct 2017
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benchmark Ear Impression Techniques
- ClinicalTrials.gov ID
- NCT03303183
- Acronym / sponsor ID
- KEK-ZH Nr.2014-0326
- Conditions
- Ear Anatomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 5 Oct 2017 (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.
The purpose of this study is to determine the scan quality of the direct ear scanner concerning consistency, accuracy and reliability and to compare the data to common silicone ear impressions by benchmarking the outcome of each impression technique on custom product dummies on participants.
Detailed description
Today's standard for ear impression techniques is the impression taking process with silicone impression material. To use the silicone impression for a hearing aid manufacturing process the geometry of the impression is needed. Modern processes scan the silicone ear impression with specific scanners. Afterwards the digitalized ear impression is uploaded in the modeling software for further proceed. A new ear impression technique is now provided with the direct ear scanner technology. The direct ear scanner can create a digital scan of the outer ear and ear canal. The scan than can directly transferred to the modeling software. The research question of this study is to determine the scan quality of the direct ear scanner concerning consistency, accuracy and reliability and to compare the data to common silicone ear impressions.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct Ear Scanner | Active comparator | Device: Direct Ear ScannerDigitale impression via direct ear scanner |
| Silicone Ear impression | Active comparator | Device: Standard Impression techniqueImpression via silicone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Only adult participants ≥ 18 years
- Informed consent form as documented by signature
- Ability to fill in a questionnaire conscientious
- Healthy outer ear (Pinna and ear canal, w/o previous surgical procedures)
Key exclusion criteria (2 listed)
- Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
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 |
|---|---|---|
| Standard Impression techniqueSilicone impression technique | Device | Silicone Ear impression |
| Direct Ear ScannerDirect Ear Scanner to scan the ear anatomy | Device | Direct Ear Scanner |
Primary outcome
Deviation of Direct ear scanner compared to silicone impressions
Time frame: 1 year
Deviation of the scan of Direct ear scanner compared to silicone impressions with two viscosities [mm]
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 26 Nov 2019.
Related trials for Ear Anatomy
Recruiting
The Effect of Anatomy-based Fitting on the Perception of Speech in Noise and Music in Single-sided Deaf Cochlear Implant Users
Cochlear Implant, Sensorineural Hearing Loss
Recruiting
Anatomy-Based Fitting in Bimodal Cochlear Implant Users
Cochlear Implant, Sensorineural Hearing Loss
Recruiting
Anatomy-Based Fitting in Unexperienced Cochlear Implant Users
Cochlear Implants, Sensorineural Hearing Loss
Recruiting
Speech Perception of a Tonotopy-based Fitting for Cochlear Implant Recipients for 6 Months With Conventional Setting
Sensorineural Hearing Loss, Bilateral
Enrolling by invitation
Impact of Anatomy-Based Cochlear Implant Programming on Early Performance
Hearing Loss, Unilateral, Cochlear Implants
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 Standard Impression technique and Direct Ear Scanner in people with Ear Anatomy, 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 4 inclusion and 2 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 26 Nov 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?
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?
Deviation of Direct ear scanner compared to silicone impressions (time frame: 1 year). 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 26 Nov 2019.