N/A
N=10
Evaluation of Sound Processor for a Transcutaneous System
Conductive Hearing Loss · Mixed Hearing Loss
Bottom Line
View on ClinicalTrials.gov: NCT03374787 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Aided Thresholds Fusion-unaided PTA — 29.6 dB
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fusion Sound Processor (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Oticon Medical
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Aided Thresholds Fusion-unaided PTA |
29.6 | — |
| SECONDARY Aided Thresholds Fusion-unaided |
10.05; 26.5; 36.5; 38.0; 28.5; 27.5 | — |
| SECONDARY Aided Thresholds Fusion PTA4 |
-0.290; -1.07; -0.78 | — |
| SECONDARY Aided Thresholds Fusion |
— | — |
| SECONDARY Aided Thresholds Fusion-BCI PTA4 |
— | — |
| SECONDARY Aided Thresholds Fusion-BCI |
— | — |
| SECONDARY Speech Intelligibility Fusion-unaided % |
— | — |
| SECONDARY Speech Intelligibility Fusion-unaided Signal to Noise Ratio (SNR) |
— | — |
| SECONDARY Speech Intelligibility Fusion % |
— | — |
| SECONDARY Speech Intelligibility Fusion SNR |
— | — |
| SECONDARY Speech Intelligibility Fusion-BCI % |
— | — |
| SECONDARY Speech Intelligibility Fusion-BCI SNR |
— | — |
| SECONDARY Magnet Strength |
— | — |
| SECONDARY IPS (Inflammation, Pain, Skin Height/Numbness) Evaluation |
— | — |
| SECONDARY Subjective Evaluation |
— | — |
| SECONDARY Subjective Evaluation SSQ |
— | — |
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 speech intelligibility and self evaluation questionnaires.
Eligibility Criteria
Inclusion Criteria
- Subjects implanted with the Bridging Bone Conductor (BBC) implant
- Subjects that have completed one year follow up in Osseofon BCI (Bone Conduction Implant) study
- Subjects available for 6 months study procedures without affecting the follow ups in the Osseofon BCI study
- Active user of the BCI SP
Exclusion Criteria
- Inability to participate in follow-ups
- Unsuitable as judged by the principle investigator or the sub-investigator
Data sourced from ClinicalTrials.gov (NCT03374787). 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.