Clinical trial NCT03848910: Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor
Official title: Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deafness; Sensoneural Single Sided
Conductive Hearing Loss
Mixed Hearing Loss
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2019-02-21
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Abbreviated Profile of Hearing Aid Benefit (APHAB)
timeFrame: Day 0 (Visit 1) and after 6 weeks (Visit 3)
measure: Speech, Spatial, and Qualities of Hearing Scale (SSQ)
timeFrame: Day 0 and after 6 weeks
measure: Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
timeFrame: Day 0 and after 6 weeks
measure: Audiometric Thresholds in Freefield, Pure Tone Average 4 (PTA4)
timeFrame: Baseline at visit 1, 6 weeks after study start at visit 3
measure: Audiometric Thresholds in Freefield, Individual Frequencies
timeFrame: 6 weeks after study start
measure: Adaptive Speech Recognition in Noise Ratio
timeFrame: Baseline at visit 1, 6 weeks after study start at visit 3
measure: Speech in Quiet
timeFrame: Baseline at visit 1, 6 weeks after study start at visit 3
measure: To Compare the Subject´s Overall Preference Regarding the Investigational Device and the Precursor Sound Processor
timeFrame: 6 weeks after study start
measure: To Assess the Subject's Experience Regarding Comfort
timeFrame: Baseline at visit 1, 6 weeks after study start at visit 3
measure: To Assess the Subject's Experience Regarding Usage; Magnet Choice
timeFrame: 6 weeks after study start
measure: To Assess the Subject's Experience Regarding Usage; Battery Life Time
timeFrame: 6 weeks after study start
measure: To Assess the Subject's Experience Regarding Usage; Softwear Pad
timeFrame: 6 weeks after study start
measure: To Assess the Subject's Experience Regarding Usage; Safety Line
timeFrame: 6 weeks after study start
measure: To Assess the Subject's Experience Regarding Usage; Wireless Accessories
timeFrame: 6 weeks after study start
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: HEARing CRC550 Swanston Street, Carlton
state: Victoria
Study officials:
affiliation: HEARing CRC550, Carlton, Melbourne
name: Robert Cowan, Prof
role: PRINCIPAL_INVESTIGATOR
References: