NCT02895477

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2017

Completed
Last Updated

January 30, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

August 29, 2016

Last Update Submit

January 27, 2017

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (4)

  • 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 (2)

  • sound quality ratings

    after 6 and 12 weeks

  • questionnaires

    after 2, 6, 8 and 12 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Hearing aid

Device: hearing aid

Test group

EXPERIMENTAL

Hearing aid

Device: hearing aid

Interventions

hearing aidDEVICE
Intervention groupTest group

Eligibility Criteria

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

You may qualify if:

  • 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)

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
  • 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

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 Design

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

Study Record Dates

First Submitted

August 29, 2016

First Posted

September 9, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2016

Study Completion

January 20, 2017

Last Updated

January 30, 2017

Record last verified: 2017-01

Locations

CH(1)