Optimisation of Hybrid Fittings for Cochlear Implant Recipients

Study Overview
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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.

Official Title
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Optimisation of Hybrid Fittings for Newly Implanted Cochlear Implant Recipients

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: Hybrid fittings for cochlear implant recipients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (≥18 years of age) 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). Implanted with the CI500 or CI24RE-series cochlear implants User of the commercially available Nucleus 6 sound processor User of the ACE strategy Native speaker in the language used to assess speech perception performance Willingness to participate in and to comply with all requirements of the protocol Exclusion Criteria: Additional handicaps that would prevent participation in evaluations Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and investigational device

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cochlear Implant Recipients<br>Newly implanted cochlear implant recipients with post-implantation acoustic hearing. | Device: Hybrid fittings for cochlear implant recipients<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cochlear implants, Hybrid fittings, Cross-over frequency