NCT02545569

Brief Summary

The purpose of this evaluation is to receive the greatest benefit of new custom made hearing product technology and shell modification for the end customer and to continual improve the custom made hearing products.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 10, 2015

Completed
4.3 years until next milestone

Study Start

First participant enrolled

January 6, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 30, 2019

Status Verified

August 1, 2019

Enrollment Period

11 months

First QC Date

August 19, 2015

Last Update Submit

August 28, 2019

Conditions

Hearing Loss, Bilateral or Unilateral

Outcome Measures

Primary Outcomes (6)

  • Objective measurement of speech intelligibility related to the intervention.

    SNR (speech to noise ratio) in decibel.

    5 years

  • Objective measurement of the transfer function related to the intervention.

    REM (real ear measurement) in decibel.

    5 years

  • Objective measurement from the position of the outer ear related to the test subject.

    Measurement in degree.

    5 years

  • Objective measurement from the size of the outer ear related to the test subject.

    Measurement in micron.

    5 years

  • Objective measurement of humidity in the ear canal related to the test subject and the intervention.

    Measurement in percent.

    5 years

  • Objective measurement of temperature in the ear canal related to the test subject and the intervention.

    Measurement in degree centigrade.

    5 years

Secondary Outcomes (1)

  • Subjective rating of the intervention via questionnaire.

    5 years

Study Arms (2)

Hearing Device Type A

ACTIVE COMPARATOR

In the ear (ITE) hearing aid, 1-3 weeks wearing

Device: hearing aid (MD class IIa) - ITE, BTE, RIC

Hearing Device Type B

EXPERIMENTAL

In the ear (ITE) hearing aid, 1-3 weeks wearing

Device: hearing aid (MD class IIa) - ITE, BTE, RIC

Interventions

hearing aid (MD class IIa) - ITE, BTE, RICDEVICE

Hearing aid means any wearable instrument or device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing.

Also known as: hearing accessory (MD class I) - DM systems, FM systems, remote control
Hearing Device Type AHearing Device Type B

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Only adult participants between 18 and 99 years
  • lnformed Consent as documented by signature (Appendix lnformed Consent Form)
  • Ability to fill in a questionnaire conscientious
  • Healthy outer ear (w/o previous surgical procedures)

You may not qualify if:

  • 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
  • lnability to produce a reliable hearing test result when pure tone audiometry is attempted by the audiologist
  • Massively limited dexterity
  • Psychological problems
  • Central hearing problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sonova AG

Stäfa, Canton of Zurich, 8712, Switzerland

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Wearable Electronic DevicesElectrical Equipment and SuppliesEquipment and SuppliesSensory Aids

Study Officials

  • Jana-Kosima Schwarzlos, B.Sc.

    Switzerland, Sonova AG, CH-8712 Staefa, Zurich

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jana-Kosima Schwarzlos, B.Sc.

CONTACT

+41 58 928 0101JanaKosima.Schwarzlos@sonova.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2015

First Posted

September 10, 2015

Study Start

January 6, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

August 30, 2019

Record last verified: 2019-08

Locations

CH(1)