Neuro 1 vs. Neuro 2 Sound Processors | NCT03756337

Studies
Neuro 1 vs. Neuro 2 Sound Processors

NCT03756337

Sponsor

Oticon Medical

Status

Completed

Last Update Posted

Oct 20, 2021Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Hearing Loss, Sensorineural
Cochlear Hearing Loss

Interventions

Neuro 1 & Neuro 2
Neuro 2 & Neuro 1

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2019Actual

Primary Completion Date

Jan 10, 2020Actual

Completion Date

Jan 10, 2020Actual

First Submitted Date

Nov 26, 2018

First Submission Date that Met QC Criteria

Nov 26, 2018

First Posted Date

Nov 28, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2021

Last Update Posted Date

Oct 20, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Neuro 2 Upgrade	Experimental	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
Neuro 1 Downgrade	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neuro 1 & Neuro 2	Device	participant common fitting map used for tests	Neuro 2 Upgrade

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Peter Morris, MD	Dalhousie University, Halifax,NS, Canada	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nova Scotia Hearing and Speech centres		Halifax			Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006319	Hearing Loss, Sensorineural

Ancestor Terms

ID	Term
D034381	Hearing Loss
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided