Optimisation of Hybrid Fittings for Cochlear Implant Recipients

Not Applicable

Terminated

• Conditions: Hearing Loss
• Interventions: Device: Hybrid fittings for cochlear implant recipients

• Registration Number: NCT02765386
• Lead Sponsor: The Hearing Cooperative Research Centre

Brief Summary

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

Not available

Study Timeline

• Study Start: 2015-10-07
• Study First Submitted: 2016-04-14
• Study First Submitted QC: 2016-05-04
• Study First Posted: 2016-05-06
• Primary Completion: 2018-09-19
• Study Completion: 2020-05-08
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-02
• Last Update Posted: 2021-07-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cochlear Implant Recipients	Hybrid fittings for cochlear implant recipients	Newly implanted cochlear implant recipients with post-implantation acoustic hearing.

Primary Outcome Measures

Name	Time	Method
Speech, Spatial and Qualities of Hearing (SSQ) scale	Testing at 18, 19, 22 and 25 weeks post-activation of cochlear implant	Preference rating assessed using SSQ scale
Speech recognition in noise	Testing at 12, 15, 18, 19, 22 and 25 weeks post-activation of cochlear implant	Open-set speech recognition in noise
Word recognition scores in quiet	Testing at 12, 15, 18, 19, 22 and 25 weeks post-activation of cochlear implant	Open-set monosyllabic word scores in quiet

Trial Locations

Locations (1)

The HEARing CRC; 🇦🇺 Melbourne, Victoria, Australia