Pre-calculation for Frequency Lowering With Hearing Devices | NCT05733169

Studies
Pre-calculation for Frequency Lowering With Hearing Devices

NCT05733169

Sponsor

Sonova AG

Status

Completed

Last Update Posted

Aug 30, 2023Actual

Enrollment

8Actual

Phase

Not Applicable

Conditions

Frequency Lowering

Interventions

Frequency lowering intervention
Frequency lowering reference

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

Aug 2023

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

Jan 16, 2023Actual

Primary Completion Date

Apr 4, 2023Actual

Completion Date

Apr 4, 2023Actual

First Submitted Date

Jan 27, 2023

First Submission Date that Met QC Criteria

Feb 16, 2023

First Posted Date

Feb 17, 2023Actual

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

Aug 29, 2023

Last Update Posted Date

Aug 30, 2023Actual

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

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

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hearing impaired group	Experimental	The hearing impaired group will compare the reference condition with the intervention condition.	Other: Frequency lowering intervention Other: Frequency lowering reference

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Frequency lowering intervention	Other	Modified parametrization of the current frequency lowering parametrization.	Hearing impaired group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement of sound quality and audibility of high-frequency sounds for hearing-impaired subjects with the new parametrization compared to the current implementation of the parametrization.		6 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Experienced hearing aid user (minimum use duration 1 year)
Adult (minimum age: 18 years),
Experience with frequency lowering,
Hearing thresholds with N5-N7, S1, S2, S3 hearing loss
Symmetrical hearing loss (difference between ears <= 10 dB for 1kHz-6kHz) ,
Sensorineural hearing loss,
Air Conduction - bone conduction gap <= 10 dB,
Written and spoken German,
Ability to understand instruction,
Ability to describe listening experiences,
Ability to attend to the appointments,
Ability to fill in a questionnaire conscientiously
Healthy outer ear (without previous surgical procedures)
Hearing loss within the fitting ranges of the investigational product,
Informed consent as documented by signature.

Exclusion Criteria:

Clinical contraindications deformity of the ear (closed ear canal
or absence of pinna),
Not willing to wear the hearing aid,
Fluctuating hearing that could influence the results,
Contraindications to the MD in this study, e.g. known hypersen-sitivity or allergy to the investigational product,
Limited mobility and not in the position to attend all appoint-ments,
Limited ability to describe listening impressions/experiences and the use of the hearing aid,
Inability to produce a reliable hearing test result,
Massively limited dexterity,
Known psychological problems,
Known central hearing disorders.

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

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

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