Cochlear Implant Low Power Strategy

NCT02879539 | Completed

• 1 other identifier: CRC5607
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Keywords

cochlear implants, power consumption,

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Fundamental frequency (F0) discrimination

  Testing over 18 weeks

• Speech intelligibility and helpfulness subjective ratings

  Testing over 18 weeks

• Sentence in noise scores

  Testing over 18 weeks

Study Arms (1)

MP3000-ACE strategy

EXPERIMENTAL

MP3000 sound coding strategy or ACE strategy with lower stimulation rate

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

Interventions

MP3000 sound coding strategy or ACE strategy with lower stimulation DEVICE

MP3000-ACE strategy

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) cochlear implant recipients
• Implanted with the CI500, CI24RE and Nucleus 24 Series and CI422 cochlear implants.
• User of commercially available Freedom, CP810 or CP900 series sound processor
• User of the ACE strategy or MP3000 strategy
• At least 3 months experience with the cochlear implant
• 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

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2016
• First Posted: August 25, 2016
• Study Start: March 31, 2015
• Primary Completion: January 27, 2017
• Study Completion: January 27, 2017
• Last Updated: July 6, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)