- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05628285
Evaluation of a Hearing Device for Transmitting Sound to the Inner Ear
October 31, 2023 updated by: Oticon Medical
Evaluation of a Sound Processor for a Transcutaneous System
A single center study evaluating the performance of an externally worn sound processor for a transcutaneous bone anchored hearing system using audiological outcomes measures such as aided thresholds and self-evaluation questionnaires.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Bone conduction hearing systems use the body's natural ability to transfer sound through bone conduction.
The sound processor picks up sound and converts it into vibrations that are transferred through the skull bone to the inner ear (cochlea).
Thus, for patients with conductive or mixed hearing losses, patients with lasting hearing loss following a middle ear disease or malformations (such as microtia), the vibrations are bypassing the conductive problem in the ear canal or middle ear.
Bone conduction devices currently on the market are divided into three types; transcutaneous direct drive, percutaneous (skin penetrating) direct drive and transcutaneous skin drive bone conduction devices.
This evaluation focus on a sound processor used for a transcutaneous system.
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ann-Charlotte Persson
- Phone Number: 0046 70 960 92 16
- Email: ann-charlotte.l.persson@vgregion.se
Study Locations
-
-
-
Gothenburg, Sweden, 41663
- Habilitation & Health, Hearing organization
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Signed Informed Consent Form
- Adult subjects (18 years or older)
- Subjects implanted with an I1 implant
- Fluent in Swedish
Exclusion Criteria:
- Subjects who do not have the ability or are un-willing to follow investigational procedures/requirements, e.g., to complete questionnaires, according to investigator's discretion.
- Subject deemed unsuitable for any medical or other reason as judged by PI or medical responsible.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sentio 1 sound processor
The sound processor picks up the sound and transfer it to the implant that convert the sound to vibrations that are transmitted to the inner ear.
|
Sound processor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess the improvement of hearing with the Sentio1 (PTA4)
Time Frame: 1 month
|
Functional gain with Sentio 1, i.e., the difference in dB between unaided and aided sound field thresholds, calculated on average for frequencies 500, 1000, 2000 and 4000 Hz (PTA4).
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess the improvement of hearing with the Sentio1
Time Frame: 1 month
|
Functional gain with Sentio 1, i.e., the difference in dB between unaided and aided sound field thresholds, for all measured frequencies.
|
1 month
|
Subjective evaluation of sound processor performance. Measured by the Speech, Spatial and Quality (SSQ) scale from 0-10 where 0 represents "Not at all" and 10 represents "Perfect". Higher scores mean a better outcome.
Time Frame: 1 month
|
Sentio 1 compared to previous sound processor.
|
1 month
|
Subjective sound processor preference
Time Frame: 1 month
|
Percentage (%) of subjects who prefer the Sentio 1 over current sound processor
|
1 month
|
To assess the degree to which Sentio 1 compensates for the BC hearing loss
Time Frame: 1 month
|
|
1 month
|
To assess the difference between BC in-situ thresholds measured with Sentio 1 and conventional unmasked BC audiometry.
Time Frame: 1 month
|
Difference in dB between Sentio 1 BC in situ thresholds and BC thresholds measured with conventional unmasked BC audiometry for the frequencies 500, 1000, 2000, 3000 and 4000 Hz
|
1 month
|
Assess safety with the Sentio 1 sound processor
Time Frame: 12 months
|
Tabulation of AEs occurred throughout the investigation and percentage of individuals with reported AEs.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ann-Charlotte Persson, Habilitation & Health, Hearing organization Södra Gubberogatan 6, 416 63 Göteborg, Sweden
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 15, 2022
Primary Completion (Actual)
April 25, 2023
Study Completion (Estimated)
January 1, 2024
Study Registration Dates
First Submitted
November 8, 2022
First Submitted That Met QC Criteria
November 17, 2022
First Posted (Actual)
November 28, 2022
Study Record Updates
Last Update Posted (Actual)
November 1, 2023
Last Update Submitted That Met QC Criteria
October 31, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BC114
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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