Cochlear Implant Low Power Strategy

Hearing Loss Clinical Trial

Official title:

Clinical Assessment of a Low Power Strategy for Cochlear Implant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02879539
• Other study ID #: CRC5607
• Status: Completed
• Phase: N/A
• Start date: March 31, 2015
• Est. completion date: January 27, 2017

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

Reducing power consumption in the cochlear implant is crucial to the development of future smaller sound processors. The commercial MP3000 sound coding strategy has been shown to be more efficient in power consumption to the standard ACE strategy. However in order to develop smaller sound processors, further battery life power savings are required. The aim of this study is to evaluate three experimental sets of MP3000 parameter sets, compared against the default ACE program. In the background for each of the four strategies, experimental noise reduction programs (SpatialNR and NR3) will also be in use. In an additional phase of the study, low stimulation rate ACE programs will also be evaluated against the default stimulation rate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 27, 2017
• Est. primary completion date: January 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult (>18 years) cochlear implant recipients

2. Implanted with the CI500, CI24RE and Nucleus 24 Series and CI422 cochlear implants.

3. User of commercially available Freedom, CP810 or CP900 series sound processor

4. User of the ACE strategy or MP3000 strategy

5. At least 3 months experience with the cochlear implant

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

Intervention

Device:
• MP3000 sound coding strategy or ACE strategy with lower stimulation

Locations

Country	Name	City	State
Australia	The HEARing CRC	Melbourne	Victoria

Sponsors (3)

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

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Word recognition scores in quiet	Word recognition scores in quiet for i) MP3000 strategy compared to default ACE strategy and ii) lower rate stimulation for ACE strategy	Testing over 18 weeks
Primary	Sentence recognition scores in quiet	Sentence recognition scores in quiet for i) MP3000 strategy compared to ACE strategy and ii) lower rate stimulation for ACE strategy	Testing over 18 weeks
Secondary	Fundamental frequency (F0) discrimination	F0 discrimination for MP3000 strategy compared to the ACE baseline	Testing over 18 weeks
Secondary	Speech intelligibility and helpfulness subjective ratings	For MP3000 strategy compared to the default ACE baseline	Testing over 18 weeks
Secondary	Sentence in noise scores	Comparison of MP3000 program with Spatial NR and NR3 enabled versus disabled.	Testing over 18 weeks