N/A
N=11
Evaluation of a Hearing Device for Transmitting Sound to the Inner Ear
Conductive Hearing Loss · Mixed Hearing Loss
Bottom Line
View on ClinicalTrials.gov: NCT05628285 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: To Assess the Improvement of Hearing With the Sentio1 (PTA4) — 32.5 dB
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sentio 1 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Oticon Medical
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Assess the Improvement of Hearing With the Sentio1 (PTA4) |
32.5 | — |
| SECONDARY To Assess the Improvement of Hearing With the Sentio1 |
18.5; 29.5; 35.0; 33.5; 35.0; 32.0 | — |
| SECONDARY Subjective Evaluation of Sound Processor Performance. |
5.58; 6.07; 0.579; 4.34; 4.68; 0.353 | — |
| SECONDARY Subjective Sound Processor Preference |
7 | — |
| SECONDARY To Assess the Degree to Which Sentio 1 Compensates for the BC Hearing Loss |
20.5; 11.0; 1.50; 12.5; 14.5; 11.9 | — |
| SECONDARY To Assess the Difference Between BC In-situ Thresholds Measured With Sentio 1 and Conventional Unmasked BC Audiometry. |
-4.7; -3.4; -6.7; 8.2; 9.9 | — |
| SECONDARY Assess Safety With the Sentio 1 Sound Processor |
— | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05628285). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.