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OpenTrials
Completed

NCT Number: NCT02879539

Cochlear Implant Low Power Strategy

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.

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The HEARing CRC

Melbourne, Victoria, 3002, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

MP3000 sound coding strategy or ACE strategy with lower stimulation

Device

Primary outcomes

  1. Word recognition scores in quiet

    Time frame: 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

    Time frame: 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 outcomes

  1. Fundamental frequency (F0) discrimination

    Time frame: Testing over 18 weeks

    F0 discrimination for MP3000 strategy compared to the ACE baseline

  2. Speech intelligibility and helpfulness subjective ratings

    Time frame: Testing over 18 weeks

    For MP3000 strategy compared to the default ACE baseline

  3. Sentence in noise scores

    Time frame: Testing over 18 weeks

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

Sponsors and collaborators

Lead sponsor

The Hearing Cooperative Research Centre

Other

Collaborators

  • Cochlear
  • Royal Victoria Eye and Ear Hospital

Registry information

Official study title

Clinical Assessment of a Low Power Strategy for Cochlear Implant Recipients

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 25, 2016
Registry last updated
Jul 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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