Conductive Hearing LossNCT05628285
Evaluation of a Hearing Device for Transmitting Sound to the Inner Ear
A study testing Sentio 1 in people with Conductive Hearing Loss and Mixed Hearing Loss, run by Oticon Medical at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conductive Hearing Loss, Mixed Hearing Loss
- What is being tested?
- Sentio 1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSweden
- Study dates
- 15 Nov 2022to 15 Nov 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form
- Adult subjects (18 years or older)
- Subjects implanted with an I1 implant
- Fluent in Swedish
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Conductive Hearing Loss, Mixed Hearing Loss
- Being tested
- Sentio 1
- Medical subject headings
- Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentio 1Device
Sound processor
| Study group | Role | What they receive |
|---|---|---|
| Sentio 1 sound processor | Experimental | 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. Receives: Device: Sentio 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Assess the Improvement of Hearing With the Sentio1 (PTA4)
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).
In detail, for each patient, sound field thresholds are measured at the frequencies 500, 1000, 2000 and 4000 Hz for which a mean value is calculated and denoted as PTA4.
The primary outcome measure is functional gain which is the difference in PTA4 measured unaided (without sound processor) versus aided condition (with sound processor).
Measured: 1 month
Secondary outcomes (6)
To Assess the Improvement of Hearing With the Sentio1
Functional gain with Sentio 1, i.e., the difference in dB between unaided (without sound processor) and aided (with sound processor on) sound field thresholds, for all measured frequencies.
In detail, for each patient, sound field thresholds are measured at the frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz, with and without the sound processor on.
Measured: 1 month
Subjective Evaluation of Sound Processor Performance.
Sentio 1 compared to previous sound processor.
- Average SSQ12 scores with Sentio 1 for each question, sub-scales and in total.
- Average SSQ12 scores with current sound processor for each question, sub-scales and in total.
- Difference in SSQ12 scores between Sentio 1 and current sound processor for each question, sub-scales and in total.
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. For each of the scales the item outcomes are averaged. Fot the total score all items are averaged
Measured: 1 month
Subjective Sound Processor Preference
Percentage (%) of subjects who prefer the Sentio 1 over current sound processor
Measured: 1 month
To Assess the Degree to Which Sentio 1 Compensates for the BC Hearing Loss
- Effective gain defined as the difference in dB between aided sound field thresholds with Sentio 1 and unmasked BC thresholds on the aided ear(s). The effective gain is calculated for all measured frequencies.
- Effective gain with Sentio 1, see definition above, calculated in average for frequencies 500, 1000, 2000 and 4000 Hz (PTA4).
Measured: 1 month
To Assess the Difference Between BC In-situ Thresholds Measured With Sentio 1 and Conventional Unmasked BC Audiometry.
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.
The BC in-situ threshold is a measure of the inner ear functionality with the device. This should correspond to the unmasked BC thresholds measured with conventional audiometry. The difference was calculated as the threshold value measured with Sentio 1 minus the threshold value measured with conventional audiometry. Negative values indicate that the thresholds measured with Sentio 1 were lower (better) compared to those measured with conventional audiometry. Conversely, positive values indicate that the thresholds measured with Sentio 1 were higher (worse) compared to conventional audiometry. It's expected that two measurements should be comparable to each with a difference of maximum +/-5 dB.
Measured: 1 month
Assess Safety With the Sentio 1 Sound Processor
Tabulation of AEs occurred throughout the investigation and percentage of individuals with reported AEs.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start15 Nov 2022
- Primary completion25 Apr 2023
- Study completion15 Nov 2024
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 Conductive Hearing LossStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oticon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ann-Charlotte Persson, Principal investigator, Habilitation & Health, Hearing organization Södra Gubberogatan 6, 416 63 Göteborg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628285
- Sponsor's protocol ID
- BC114
- Status last verified
- Nov 2025
- First submitted
- 8 Nov 2022
- Last updated
- 3 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Sound Processor for a Transcutaneous System
- ClinicalTrials.gov ID
- NCT05628285
- Acronym / sponsor ID
- BC114
- Conditions
- Conductive Hearing Loss, Mixed Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 28 Nov 2022 (actual)
- Results
- Posted 19 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sentio 1 sound processor | Experimental | Device: Sentio 1The 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed Informed Consent Form
- Adult subjects (18 years or older)
- Subjects implanted with an I1 implant
- Fluent in Swedish
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Sentio 1Sound processor | Device | Sentio 1 sound processor |
Primary outcome
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). In detail, for each patient, sound field thresholds are measured at the frequencies 500, 1000, 2000 and 4000 Hz for which a mean value is calculated and denoted as PTA4. The primary outcome measure is functional gain which is the difference in PTA4 measured unaided (without sound processor) versus aided condition (with sound processor).
6 secondary outcomes
To Assess the Improvement of Hearing With the Sentio1
Time frame: 1 month
Subjective Evaluation of Sound Processor Performance.
Time frame: 1 month
Subjective Sound Processor Preference
Time frame: 1 month
To Assess the Degree to Which Sentio 1 Compensates for the BC Hearing Loss
Time frame: 1 month
To Assess the Difference Between BC In-situ Thresholds Measured With Sentio 1 and Conventional Unmasked BC Audiometry.
Time frame: 1 month
Assess Safety With the Sentio 1 Sound Processor
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Ann-Charlotte Persson principal investigator
Habilitation & Health, Hearing organization Södra Gubberogatan 6, 416 63 Göteborg, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentio 1 in people with Conductive Hearing Loss and Mixed Hearing Loss, run by Oticon Medical at 1 site in Sweden.
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 3 Dec 2025. 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 Sweden. 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 19 Aug 2025). 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?
To Assess the Improvement of Hearing With the Sentio1 (PTA4) (time frame: 1 month). 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 Dec 2025.