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Optimisation of Hybrid Fittings for Cochlear Implant Recipients

Optimisation of Hybrid Fittings for Newly Implanted Cochlear Implant Recipients

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02765386
Enrollment
12
Registered
2016-05-06
Start date
2015-10-07
Completion date
2020-05-08
Last updated
2021-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss

Keywords

Cochlear implants, Hybrid fittings, Cross-over frequency

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.

Interventions

DEVICEHybrid fittings for cochlear implant recipients

Sponsors

Royal Victoria Eye and Ear Hospital
CollaboratorOTHER_GOV
Cochlear
CollaboratorINDUSTRY
University of Melbourne
CollaboratorOTHER
The Hearing Cooperative Research Centre
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Speech, Spatial and Qualities of Hearing (SSQ) scaleTesting at 18, 19, 22 and 25 weeks post-activation of cochlear implantPreference rating assessed using SSQ scale
Word recognition scores in quietTesting at 12, 15, 18, 19, 22 and 25 weeks post-activation of cochlear implantOpen-set monosyllabic word scores in quiet
Speech recognition in noiseTesting at 12, 15, 18, 19, 22 and 25 weeks post-activation of cochlear implantOpen-set speech recognition in noise

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026