Neuro 1 vs. Neuro 2 Sound Processors

Not Applicable

Completed

• Conditions: Hearing Loss, Sensorineural; Cochlear Hearing Loss
• Interventions: Device: Neuro 1 & Neuro 2; Device: Neuro 2 & Neuro 1

• Registration Number: NCT03756337
• Lead Sponsor: Oticon Medical

Brief 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.

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 Timeline

• Study First Submitted: 2018-11-26
• Study First Submitted QC: 2018-11-26
• Study First Posted: 2018-11-28
• Study Start: 2019-11-01
• Primary Completion: 2020-01-10
• Study Completion: 2020-01-10
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-13
• Last Update Posted: 2021-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Neuro 2 Upgrade	Neuro 1 & Neuro 2	Participant wears Neuro 1 sound processor and is tested, then is upgraded with the new sound processor Neuro 2 and tested.
Neuro 1 Downgrade	Neuro 2 & Neuro 1	Participant wears Neuro 2 sound processor and is tested, then is downgraded with the sound processor Neuro 1 and tested.

Primary Outcome Measures

Name	Time	Method
speech recognition in quiet	Day 1	Hearing In Noise Test

Secondary Outcome Measures

Name	Time	Method
speech recognition in noise	Day 1	Hearing In Noise Test
pure tone threshold	Day 1	from 250Hz to 8kHz

Trial Locations

Locations (1)

Nova Scotia Hearing and Speech centres; 🇨🇦 Halifax, Canada