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

NCT ID: NCT03848910

Last Updated: 2021-10-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-19

Study Completion Date

2019-04-23

Brief Summary

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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).

Detailed Description

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Conditions

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Deafness; Sensoneural Single Sided Conductive Hearing Loss Mixed Hearing Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Investigational device - Sound Processor

Group Type EXPERIMENTAL

Investigational device - Sound Processor

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cochlear

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Cowan, Prof

Role: PRINCIPAL_INVESTIGATOR

HEARing CRC550, Carlton, Melbourne

Locations

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HEARing CRC550 Swanston Street, Carlton

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CBAS5731

Identifier Type: -

Identifier Source: org_study_id