Ear Mold Impression ProcedureNCT05000047
Clinical Performance Evaluation of 3D Ear Canal Scanning Technology
An observational study of Ear Mold Impression Procedure, run by Sonova AG at 1 site in United States.
Trial summary
Study participants will undergo ear canal impressions in a standard of care protocol utilizing two methodologies: 3D ear scanning using a commercially-available ear scanning device, and conventional silicone impression material. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ear Mold Impression Procedure
- What is being tested?
- 3D ear scanner and Conventional silicon ear impressions
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2021to 15 Jul 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with anatomically typical external auditory canals/meatus who have any degree, type, and configuration of hearing impairment.
Who may be able to join
- Hearing impairment (any degree, type, and configuration)
Who cannot join
- Absent or abnormal external auditory canal and/or external auditory meatus.
- Positive history of external/middle ear surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Phonak Audiology Research Center
Aurora, Illinois, 60504
About this study
Official title: 3D Ear Scanner-Workflow Timing and Preferences Compared to Traditional Silicone Earmold Impressions
Study participants will undergo ear canal impressions in a standard of care protocol utilizing two methodologies: 3D ear scanning using a commercially-available ear scanning device, and conventional silicone impression material. The elapsed time of each procedure will be captured for each participant, and the average duration of the two methodologies will be compared.
- Conditions
- Ear Mold Impression Procedure
- Being tested
- 3D ear scanner, Conventional silicon ear impressions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D ear scannerDevice
A commercially-available ear scanning device used according to standard of care. A hand-held device is used and is considered less invasive than conventional earmold impressions.
Conventional silicon ear impressionsOther
A two part silicon impression material that is used to fill the ear and produce a physical cast of the ear canal. The procedure is standard of care.
| Study group | Role | What they receive |
|---|---|---|
| All participants | All study participants who have bilateral earmold impressions completed using both a 3D ear scanner and the conventional procedure using silicone impression material. Receives: Device: 3D ear scanner; Other: Conventional silicon ear impressions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elapsed Time in Minutes to Complete Bilateral Ear Impressions
The total time in minutes, required for sub-investigators to complete each impression methodology on each participant, according to a standard of care procedure . For the silicone impressions, time was started after otoscopy and cerumen management of both ears, and just before prepping and placing the otoblocks. The timer stopped after the audiologist was satisfied with both ear impressions and placed them in box. For the ear scan, time was started after otoscopy of both ears, and just before prepping the headset and hand-held scanner. The timer stopped after the 3D scan was reviewed for each ear and audiologist satisfied with result. The time reported is how long it took for clinician to finish one complete set of impressions, which included a right and a left ear impression. Separate times for each ear was not recorded.
Measured: Day one
Secondary outcomes (7)
Subjective Feedback of Overall Experience of Both Ear Impression Procedures
Each participant answered the question "How do you rate your experience of the recently performed ear canal impression/scanning?" after each procedure. Participants rated their overall experience on a scale from 1 (worst) to 5 (best).
Measured: Day one
Subjective Feedback, Pleasantness of Experience
Each participant answered the question "How pleasant do you rate the impression/scanning procedure?" after each procedure. Participants rated the the pleasantness on a scale from 1 (very pleasant) to 5 (very unpleasant).
Measured: Day one
Subjective Feedback on the Perceived Improvement of Actual Device Fitting Using Each Impression Procedure Compared to a Non-custom Hearing Aid Fitting
Each participant answered the question at the end of each procedure- "Compared to a non-custom fitting, do you feel that the method of impression/scanning improves the hearing aid process for you?", and rated on a scale from 1 (very improved) to 5 (much worse).
Measured: Day one
Sub-investigator Clinician Subjective Rating of Ease of Procedure on a Scale From 1 (Not at All Easy) to 10 (Most Ease)
Sub-investigators answered a question after each procedure on each participant- "How easy was it to perform the procedure? on a scale from 1 (not at all easy) to 10(most ease).
Measured: Day 1
Sub-investigator Clinician Subjective Rating of Individual Potential for Improvement When Performing Each Procedure 1 (no Potential for Improvement) to 3 (a Lot of Potential for Improvement)
Sub-investigators answered a question after each procedure on each participant they saw- "Do you feel like there was any potential for improvement when performing this procedure?". Each sub-investigator rated their own potential for improvement on a scale from 1(no potential for improvement, clinician was very satisfied with impression) to 3 (a lot of potential for improvement, clinician felt impression was inferior).
Measured: Day 1
Sub-investigator Clinician Subjective Rating of Individual Confidence That Method of Impression Will Yield a Quality Custom Product for the Participant on a Scale From 1 (Not at All Confident) to 3 (Very Confident).
Sub-investigators answered a question after each procedure on each participant they saw- "How confident are you that the method of impression/scanning will yield a quality custom product?" on a scale from 1 (not at all confident) to 3 (very confident).
Measured: Day 1
Clinician Subjective Rating of Overall Experience of Each Procedure.
Clinicians answered a question after each procedure on each participant they saw- "How would you rate the overall experience of performing this procedure?" using a scale from 1 (worst) to 5 (best).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start17 May 2021
- Primary completion30 Jun 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ear Mold Impression ProcedureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin Seitz-Paquette, Principal investigator, Sonova USCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000047
- Sponsor's protocol ID
- SRF-371
- Status last verified
- May 2023
- First submitted
- 9 Jun 2021
- Last updated
- 1 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Ear Scanner-Workflow Timing and Preferences Compared to Traditional Silicone Earmold Impressions
- ClinicalTrials.gov ID
- NCT05000047
- Acronym / sponsor ID
- SRF-371
- Conditions
- Ear Mold Impression Procedure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- 17 May 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 11 Aug 2021 (actual)
- Results
- Posted 6 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study participants will undergo ear canal impressions in a standard of care protocol utilizing two methodologies: 3D ear scanning using a commercially-available ear scanning device, and conventional silicone impression material. The elapsed time of each procedure will be captured for each participant, and the average duration of the two methodologies will be compared.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | Device: 3D ear scanner, Other: Conventional silicon ear impressionsAll study participants who have bilateral earmold impressions completed using both a 3D ear scanner and the conventional procedure using silicone impression material. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with anatomically typical external auditory canals/meatus who have any degree, type, and configuration of hearing impairment.
Key inclusion criteria (1 listed)
- Hearing impairment (any degree, type, and configuration)
Key exclusion criteria (2 listed)
- Absent or abnormal external auditory canal and/or external auditory meatus.
- Positive history of external/middle ear surgery.
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 |
|---|---|---|
| 3D ear scannerA commercially-available ear scanning device used according to standard of care. A hand-held device is used and is considered less invasive than conventional earmold impressions. | Device | All participants |
| Conventional silicon ear impressionsA two part silicon impression material that is used to fill the ear and produce a physical cast of the ear canal. The procedure is standard of care. | Other | All participants |
Primary outcome
Elapsed Time in Minutes to Complete Bilateral Ear Impressions
Time frame: Day one
The total time in minutes, required for sub-investigators to complete each impression methodology on each participant, according to a standard of care procedure . For the silicone impressions, time was started after otoscopy and cerumen management of both ears, and just before prepping and placing the otoblocks. The timer stopped after the audiologist was satisfied with both ear impressions and placed them in box. For the ear scan, time was started after otoscopy of both ears, and just before prepping the headset and hand-held scanner. The timer stopped after the 3D scan was reviewed for each ear and audiologist satisfied with result. The time reported is how long it took for clinician to finish one complete set of impressions, which included a right and a left ear impression. Separate times for each ear was not recorded.
7 secondary outcomes
Subjective Feedback of Overall Experience of Both Ear Impression Procedures
Time frame: Day one
Subjective Feedback, Pleasantness of Experience
Time frame: Day one
Subjective Feedback on the Perceived Improvement of Actual Device Fitting Using Each Impression Procedure Compared to a Non-custom Hearing Aid Fitting
Time frame: Day one
Sub-investigator Clinician Subjective Rating of Ease of Procedure on a Scale From 1 (Not at All Easy) to 10 (Most Ease)
Time frame: Day 1
Sub-investigator Clinician Subjective Rating of Individual Potential for Improvement When Performing Each Procedure 1 (no Potential for Improvement) to 3 (a Lot of Potential for Improvement)
Time frame: Day 1
Sub-investigator Clinician Subjective Rating of Individual Confidence That Method of Impression Will Yield a Quality Custom Product for the Participant on a Scale From 1 (Not at All Confident) to 3 (Very Confident).
Time frame: Day 1
Clinician Subjective Rating of Overall Experience of Each Procedure.
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Kevin Seitz-Paquette principal investigator
Sonova USCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ear Mold Impression Procedure, run by Sonova AG at 1 site in United States.
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 1 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 1 Jun 2023. 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 United States. 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?
Yes. Results are posted in the registry (first posted 6 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Elapsed Time in Minutes to Complete Bilateral Ear Impressions (time frame: Day one). 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 1 Jun 2023.