Neuro 1 vs. Neuro 2 Sound Processors

October 13, 2021 updated by: Oticon Medical

Comparison of Audiometric Performance Between the Neuro 1 and 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Halifax, Canada
        • Nova Scotia Hearing and Speech Centres

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neuro 2 Upgrade
Participant wears Neuro 1 sound processor and is tested, then is upgraded with the new sound processor Neuro 2 and tested.
Device: Neuro 1 & Neuro 2
participant common fitting map used for tests
Experimental: Neuro 1 Downgrade
Participant wears Neuro 2 sound processor and is tested, then is downgraded with the sound processor Neuro 1 and tested.
Device: Neuro 2 & Neuro 1
participant common fitting map used for tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
speech recognition in quiet
Time Frame: Day 1
Hearing In Noise Test
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
speech recognition in noise
Time Frame: Day 1
Hearing In Noise Test
Day 1
pure tone threshold
Time Frame: Day 1
from 250Hz to 8kHz
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oticon Medical

Investigators

  • Principal Investigator: David Peter Morris, MD, Dalhousie University, Halifax,NS, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Actual)

January 10, 2020

Study Completion (Actual)

January 10, 2020

Study Registration Dates

First Submitted

November 26, 2018

First Submitted That Met QC Criteria

November 26, 2018

First Posted (Actual)

November 28, 2018

Study Record Updates

Last Update Posted (Actual)

October 20, 2021

Last Update Submitted That Met QC Criteria

October 13, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIC-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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