NCT03848910

Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Cochlear · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Deafness; Sensoneural Single Sided
• Conductive Hearing Loss
• Mixed Hearing Loss

Interventions

Type	Name	Description
DEVICE	Investigational device - Sound Processor	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.

Timeline

• Start date: 2019-02-19
• Primary completion: 2019-04-23
• Completion: 2019-04-23
• First posted: 2019-02-21
• Last updated: 2021-10-14
• Results posted: 2020-02-05

Locations

1 site across 1 country: Australia