Cochlear Implant Low Power Strategy

• Sponsor: The Hearing Cooperative Research Centre (Other)
• Overall Status: Completed
• CT.gov ID: NCT02879539
• Collaborator: Royal Victoria Eye and Ear Hospital (Other), Cochlear (Industry)
• Enrollment: 32
• Location: 1
• Arm: 1
• Actual Duration (Months): 21.9
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hearing Loss	Device: MP3000 sound coding strategy or ACE strategy with lower stimulation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Assessment of a Low Power Strategy for Cochlear Implant Recipients
• Actual Study Start Date: Mar 31, 2015
• Actual Primary Completion Date: Jan 27, 2017
• Actual Study Completion Date: Jan 27, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MP3000-ACE strategy MP3000 sound coding strategy or ACE strategy with lower stimulation rate	Device: MP3000 sound coding strategy or ACE strategy with lower stimulation

Outcome Measures

Primary Outcome Measures

1. Word recognition scores in quiet [Testing over 18 weeks]

   Word recognition scores in quiet for i) MP3000 strategy compared to default ACE strategy and ii) lower rate stimulation for ACE strategy

2. Sentence recognition scores in quiet [Testing over 18 weeks]

   Sentence recognition scores in quiet for i) MP3000 strategy compared to ACE strategy and ii) lower rate stimulation for ACE strategy

Secondary Outcome Measures

1. Fundamental frequency (F0) discrimination [Testing over 18 weeks]

   F0 discrimination for MP3000 strategy compared to the ACE baseline

2. Speech intelligibility and helpfulness subjective ratings [Testing over 18 weeks]

   For MP3000 strategy compared to the default ACE baseline

3. Sentence in noise scores [Testing over 18 weeks]

   Comparison of MP3000 program with Spatial NR and NR3 enabled versus disabled.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The HEARing CRC	Melbourne	Victoria	Australia	3002

Sponsors and Collaborators

• The Hearing Cooperative Research Centre
• Royal Victoria Eye and Ear Hospital
• Cochlear

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Hearing Cooperative Research Centre
• ClinicalTrials.gov Identifier: NCT02879539
• Other Study ID Numbers: CRC5607
• First Posted: Aug 25, 2016
• Last Update Posted: Jul 6, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by The Hearing Cooperative Research Centre: cochlear implants, power consumption,
• Additional relevant MeSH terms: Hearing Loss

Study Results

No Results Posted as of Jul 6, 2021