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Neuro 1 vs. Neuro 2 Sound Processors

NCT ID: NCT03756337

Last Updated: 2021-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-01-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hearing Loss, Sensorineural Cochlear Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Neuro 2 Upgrade

Participant wears Neuro 1 sound processor and is tested, then is upgraded with the new sound processor Neuro 2 and tested.

Group Type EXPERIMENTAL

Neuro 1 & Neuro 2

Intervention Type DEVICE

participant common fitting map used for tests

Neuro 1 Downgrade

Participant wears Neuro 2 sound processor and is tested, then is downgraded with the sound processor Neuro 1 and tested.

Group Type EXPERIMENTAL

Neuro 2 & Neuro 1

Intervention Type DEVICE

participant common fitting map used for tests

Interventions

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Neuro 1 & Neuro 2

participant common fitting map used for tests

Intervention Type DEVICE

Neuro 2 & Neuro 1

participant common fitting map used for tests

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oticon Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Peter Morris, MD

Role: PRINCIPAL_INVESTIGATOR

Dalhousie University, Halifax,NS, Canada

Locations

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Nova Scotia Hearing and Speech centres

Halifax, , Canada

Site Status

Countries

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Canada

Other Identifiers

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PIC-20

Identifier Type: -

Identifier Source: org_study_id