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NCT03756337 Clinical Trial

Neuro 1 vs. Neuro 2 Sound Processors

Hearing Loss, Sensorineural Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03756337
Other study ID # PIC-20
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2019
Est. completion date January 10, 2020

Study information
Verified date October 2021
Source Oticon Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date January 10, 2020
Est. primary completion date January 10, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Neuro 1 & Neuro 2
participant common fitting map used for tests
• Neuro 2 & Neuro 1
participant common fitting map used for tests

Locations
Country Name City State
Canada Nova Scotia Hearing and Speech centres Halifax

Sponsors (1)
Lead Sponsor Collaborator
Oticon Medical

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary speech recognition in quiet Hearing In Noise Test Day 1
Secondary speech recognition in noise Hearing In Noise Test Day 1
Secondary pure tone threshold from 250Hz to 8kHz Day 1
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