Quest Sound Recover (SR2) vs. Venture SR2 | NCT02895477

Studies
Quest Sound Recover (SR2) vs. Venture SR2

NCT02895477

Sponsor

Sonova AG

Status

Completed

Last Update Posted

Jan 30, 2017Estimated

Enrollment

23Actual

Phase

Not Applicable

Conditions

Hearing Loss

Interventions

hearing aid

Countries

Switzerland

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

Jan 2017

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

Jul 2016

Primary Completion Date

Dec 2016Actual

Completion Date

Jan 20, 2017Actual

First Submitted Date

Aug 29, 2016

First Submission Date that Met QC Criteria

Sep 5, 2016

First Posted Date

Sep 9, 2016Estimated

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

Jan 27, 2017

Last Update Posted Date

Jan 30, 2017Estimated

Description Module

Brief Summary

Goal of this study is to determine the benefit of an improved feature on a new hearing aid platform.

To investigate the improvements of this feature is compared on a new and older hearing aid platform. The obtained results will be used for future improvement for this feature. This feature should improve the speech understanding and speech recognition of the hearing aid user.

Detailed Description

Not provided

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

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention group	Experimental	Hearing aid	Device: hearing aid
Test group	Experimental	Hearing aid	Device: hearing aid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hearing aid	Device		Intervention group Test group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Functional gain	Functional gain is to measure the aided threshold (in dB hearing level [HL]) in free field via loudspeaker.	after 2 weeks
Phoneme Perception Test	Change of Detection thresholds after 4 weeks hearing instrument wearing time	after 2
Functional gain	Functional gain is to measure the aided threshold (in dB hearing level [HL]) in free field via loudspeaker.	after 8 weeks
Phoneme Perception Test	Change of detection thresholds after 4 weeks hearing instrument wearing time	after 8 weeks

Secondary Outcomes

Measure	Description	Time Frame
sound quality ratings		after 6 and 12 weeks
questionnaires		after 2, 6, 8 and 12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Informed Consent as documented by signature (Appendix Informed Consent Form)
Ability to fill in a question conscientious
Healthy outer ear (w/o previous surgical procedures)
Sensorineural symmetric hearing loss (HL)
N4 to N7 (degree of HL)

Exclusion Criteria:

Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product,
Limited mobility and not in the position to attend weekly appointments
Limited ability to describe listening impressions/experiences and the use of the hearing aid
Inability to produce a reliable hearing test result when pure tone audiometry is attempted by the audiologist
Massively limited dexterity
Known Psychological problems
Central hearing problems

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sonova AG		Stäfa	Canton of Zurich	8712	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D034381	Hearing Loss

Ancestor Terms

ID	Term
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D012678	Sensation Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006310	Hearing Aids

Ancestor Terms

ID	Term
D000076251	Wearable Electronic Devices
D055615	Electrical Equipment and Supplies
D004864	Equipment and Supplies
D012682	Sensory Aids

Browse Leaves

Not provided

Browse Branches

Not provided