N/A
N=11
Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor
Deafness; Sensoneural Single Sided · Conductive Hearing Loss · Mixed Hearing Loss
Bottom Line
View on ClinicalTrials.gov: NCT03848910 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Abbreviated Profile of Hearing Aid Benefit (APHAB) — 6.3; 7.0; 5.6; 3.5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Investigational device - Sound Processor (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cochlear
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Abbreviated Profile of Hearing Aid Benefit (APHAB) |
6.3; 7.0; 5.6; 3.5; 6.3 | — |
| PRIMARY Speech, Spatial, and Qualities of Hearing Scale (SSQ) |
1.0; 0.061; 0.96; 0.68 | — |
| PRIMARY Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2) |
0; 0; 3; 4; 4; 0 | — |
| PRIMARY Audiometric Thresholds in Freefield, Pure Tone Average 4 (PTA4) |
-2.5 | — |
| PRIMARY Audiometric Thresholds in Freefield, Individual Frequencies |
-2.3; -3.6; -6.4; -3.6; -3.6; -1.2 | — |
| PRIMARY Adaptive Speech Recognition in Noise Ratio |
-1.3; -1.2 | — |
| PRIMARY Speech in Quiet |
82.5; 83.3; 93.7; 96.9; 94.4; 96.9 | — |
| PRIMARY To Compare the Subject´s Overall Preference Regarding the Investigational Device and the Precursor Sound Processor |
0; 0; 11 | — |
| PRIMARY To Assess the Subject's Experience Regarding Comfort |
84.9; 87.5 | — |
| PRIMARY To Assess the Subject's Experience Regarding Usage; Magnet Choice |
1; 3; 3; 4 | — |
| PRIMARY To Assess the Subject's Experience Regarding Usage; Battery Life Time |
2; 1; 2; 3; 1; 1 | — |
| PRIMARY To Assess the Subject's Experience Regarding Usage; Softwear Pad |
2; 9 | — |
| PRIMARY To Assess the Subject's Experience Regarding Usage; Safety Line |
9; 2 | — |
| PRIMARY To Assess the Subject's Experience Regarding Usage; Wireless Accessories |
11; 0 | — |
Summary
The aim of this clinical investigation is to investigate the subject´s overall preference, hearing performance and self-reported assessments with the Investigational device and its precursor Sound Processor (Comparator) after 6 weeks in subjects with conductive/mixed hearing loss or Single Sided Deafness, (SSD).
Eligibility Criteria
Inclusion Criteria
- Completed clinical investigation CBAS5539, and an active user of the Osia System.
- Signed Informed consent.
- Subject with conductive or mixed hearing loss in the implanted ear. Bone conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 4 kHz) of ≤ 55 dB HL.
OR subject with single-sided sensorineural deafness. Air conduction thresholds with a pure tone average PTA4 of ≤ 20 dB (decibel) HL (Hearing Level) (mean of 0.5, 1, 2 and 3 kHz) in the good ear.
- Optimally fitted with Osia Sound processor, according to subject's experience prior to inclusion.
Exclusion Criteria
- Any ongoing soft tissue complication that could significantly affect the use of the Osia 2 Sound Processor during the 6 weeks period
- Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator
- Unable to follow investigational procedures and instructions, e.g. inability to complete quality of life scales or audiological testing as described in the Clinical Investigation Plan (CIP).
- Participation in another clinical investigation with pharmaceutical and/or device.
Data sourced from ClinicalTrials.gov (NCT03848910). 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.