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
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Cochlear Hearing Loss
• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural

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