Optimisation of Hybrid Fittings for Cochlear Implant Recipients

NCT ID: NCT02765386

Last Updated: 2021-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-07

Study Completion Date

2020-05-08

Brief Summary

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When providing amplification post-implantation to residual acoustic hearing in the implanted ear, the lower frequency boundary can be modified to minimize or avoid overlap between the frequencies coded through acoustic hearing and those presented through electrical stimulation. This boundary is termed the cross-over frequency (Fc) and the effect of modifying this parameter will be investigated in this study. To avoid the research being confounded by prior bias for a particular frequency allocation, the study will be conducted with newly implanted recipients.

This study will also investigate whether tests which measure the ability to use low frequency hearing and objective measures can predict the preferred Fc and speech performance benefit.

Detailed Description

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Conditions

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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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Cochlear Implant Recipients

Newly implanted cochlear implant recipients with post-implantation acoustic hearing.

Group Type EXPERIMENTAL

Hybrid fittings for cochlear implant recipients

Intervention Type DEVICE

Interventions

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Hybrid fittings for cochlear implant recipients

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Adult (≥18 years of age)
2. Post-operative residual hearing in the implanted ear (defined as having an unaided threshold better than or equal to 80 dB HL at the 500 Hz frequency).
3. Implanted with the CI500 or CI24RE-series cochlear implants
4. User of the commercially available Nucleus 6 sound processor
5. User of the ACE strategy
6. Native speaker in the language used to assess speech perception performance
7. Willingness to participate in and to comply with all requirements of the protocol

Exclusion Criteria

1. Additional handicaps that would prevent participation in evaluations
2. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and investigational device
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Victoria Eye and Ear Hospital

OTHER_GOV

Sponsor Role collaborator

Cochlear

INDUSTRY

Sponsor Role collaborator

University of Melbourne

OTHER

Sponsor Role collaborator

The Hearing Cooperative Research Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The HEARing CRC

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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CRC5610

Identifier Type: -

Identifier Source: org_study_id

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