At a glance
ClinicalIndex Comparison Record- ✓Completed prior clinical investigation CBAS5539 and actively using Osia System
- ✓Conductive or mixed hearing loss with bone conduction thresholds PTA4 ≤55 dB HL in implanted ear
- ✓Single-sided sensorineural deafness with air conduction thresholds PTA4 ≤20 dB HL in good ear
- ✓Optimally fitted with Osia Sound processor per subject's prior experience
- ✕Active soft tissue complication that could significantly impair use of the Osia 2 Sound Processor during the 6-week study
- ✕Current use of ototoxic drugs judged harmful to hearing by the investigator
- ✕Unable to follow investigational procedures including quality of life scales or audiological testing
- ✕Concurrent participation in another clinical investigation involving pharmaceutical and/or device
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor
In Brief
A clinical study evaluating Investigational device - Sound Processor for Deafness; Sensoneural Single Sided and 2 related conditions. Completed, enrolled 11 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
At visit 1 the subjects will complete self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects will then receive the Investigational device (Sound Processor) which should be used during the following 6 weeks. At visit 3 the subjects will complete self-reported assessments regarding Investigational device and participate in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject shall decide their preferred choice made by selection between Investigational device and the comparator.