Optimisation of Hybrid Fittings for Cochlear Implant Recipients

NCT02765386 | Terminated

• 1 other identifier: CRC5610
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Keywords

Cochlear implants; Hybrid fittings; Cross-over frequency

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Cochlear Implant Recipients

EXPERIMENTAL

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

Device: Hybrid fittings for cochlear implant recipients

Interventions

Hybrid fittings for cochlear implant recipients DEVICE

Cochlear Implant Recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hearing Cooperative Research Centre: lead
• Royal Victoria Eye and Ear Hospital: collaborator
• Cochlear: collaborator
• University of Melbourne: collaborator

Study Sites (1)

The HEARing CRC

Melbourne, Victoria, 3002, Australia

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: May 6, 2016
• Study Start: October 7, 2015
• Primary Completion: September 19, 2018
• Study Completion: May 8, 2020
• Last Updated: July 6, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)