Evaluation of Frequency Lowering Technique | NCT02303210

Studies
Evaluation of Frequency Lowering Technique

NCT02303210

Sponsor

Phonak AG, Switzerland

Status

Completed

Last Update Posted

Sep 25, 2017Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Hearing Loss

Interventions

hearing aid NaidaUP
hearing aid NaidaSP

Countries

Germany

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

Sep 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

Dec 2014

Primary Completion Date

Mar 2015Actual

Completion Date

Mar 2015Actual

First Submitted Date

Nov 3, 2014

First Submission Date that Met QC Criteria

Nov 24, 2014

First Posted Date

Nov 27, 2014Estimated

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

Sep 20, 2017

Last Update Posted Date

Sep 25, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to examine two frequency lowering techniques in case of audibility, recognition, distinction, discriminability and sound quality.

Detailed Description

This is a controlled, single blinded and randomised comparative study which is conducted monocentric at Hoerzentrum Oldenburg, Germany. The focus is to test two frequency lowering techniques with an amount of 30 moderate to severe, symmetrically sensorineural hearing impaired adult subjects. The subjects, all of them native German speakers, individually conduct a number of laboratory standard tests and home trials (questionnaires) during 6 months including seven appointments of 2 hours.

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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
hearing aid NaidaUP	Other	Within subject design: compare frequency lowering one with frequency lowering two.	Device: hearing aid NaidaUP
hearing aid NaidaSP	Other	Within subject design: compare frequency lowering one with frequency lowering two.	Device: hearing aid NaidaSP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hearing aid NaidaUP	Device	Standard Power Hearing instruments including different frequency lowering techniques	hearing aid NaidaUP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Audibility improvement (Delta of dB SPL thresholds) of high frequency sounds measured with a Phoneme Perception Test.		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

female and male adults (>18 years old)
mild to severe Hearing Loss
symmetric Hearing Loss
german native speakers

Exclusion Criteria:

persons who are not able to attend multiple appointments
persons who are not able to handle a hearing aid
persons with a mental handicap
persons with limited access to multiple hearing situations
persons with psychological disease
no acclimatization to hearing aids

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
Julia Rehmann, B.Sc.	Phonak AG	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hoerzentrum Oldenburg		Oldenburg	Lower Saxony	26129	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

National Regulations do not require to share data,

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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