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OpenTrials
Completed

NCT Number: NCT03756337

Neuro 1 vs. Neuro 2 Sound Processors

This study evaluates the benefit of Neuro 1 sound processor upgrade in speech perfomance in adults. Half of participants will be tested with Neuro 1 first and Neuro 2, while the other half will be tested with Neuro 2 first and then Neuro 1.

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Key information

Conditions

Hearing Loss, Sensorineural Cochlear Hearing Loss Ear Diseases Hearing Disorders Hearing Loss 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

Nova Scotia Hearing and Speech centres

Halifax, Canada

About this study

The Neuro 1 processor represented a technological advancement over past models, particularly in detecting the environment and automatically adjusting to the sound environment. A second version of the Neuro 1 processor has been developed, the Neuro 2. The signal processing and stimulation characteristics are similar, so speech comprehension levels are expected to be equivalent. This study is designed to compare Neuro 1 and Neuro 2 in terms of audiometric performance.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • written informed consent
  • primary implantation
  • subject having participated to previous Neuro 1 sound processor study in Canada
  • fluent in English, including reading and writing.

Exclusion criteria

  • psychologically unsuitable
  • unrealistic expectations regarding possible benefits, risks, and limitations that are inherent to the device
  • non compliant with all investigational requirements.

Treatment and study plan

Neuro 1 & Neuro 2

Device

participant common fitting map used for tests

Neuro 2 & Neuro 1

Device

participant common fitting map used for tests

Primary outcomes

  1. speech recognition in quiet

    Time frame: Day 1

    Hearing In Noise Test

Secondary outcomes

  1. speech recognition in noise

    Time frame: Day 1

    Hearing In Noise Test

  2. pure tone threshold

    Time frame: Day 1

    from 250Hz to 8kHz

Sponsors and collaborators

Lead sponsor

Oticon Medical

Industry

Registry information

Official study title

Comparison of Audiometric Performance Between the Neuro 1 and Neuro 2 Sound Processors.

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 28, 2018
Registry last updated
Oct 20, 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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