Optimisation of Hybrid Fittings for Cochlear Implant Recipients

Hearing Loss Clinical Trial

Official title:

Optimisation of Hybrid Fittings for Newly Implanted Cochlear Implant Recipients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02765386
• Other study ID #: CRC5610
• Status: Terminated
• Phase: N/A
• Start date: October 7, 2015
• Est. completion date: May 8, 2020

Study information

• Verified date: July 2021
• Source: The Hearing Cooperative Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: May 8, 2020
• Est. primary completion date: September 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss
• Seizures

Intervention

Device:
• Hybrid fittings for cochlear implant recipients

Locations

Country	Name	City	State
Australia	The HEARing CRC	Melbourne	Victoria

Sponsors (4)

Lead Sponsor	Collaborator
The Hearing Cooperative Research Centre	Cochlear, Royal Victoria Eye and Ear Hospital, University of Melbourne

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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