NCT03131557

Brief Summary

A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of participants with a hearing loss to grant quality control prior to product launch. The aim of the investigation series is to ensure usability, zero-defect overall performance of the new hearing systems as well as maximum benefit for the participant with the devices in comparison to previously outstanding Phonak Hearing Systems.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

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

First Submitted

Initial submission to the registry

April 24, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 12, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2017

Completed
Last Updated

August 17, 2017

Status Verified

August 1, 2017

Enrollment Period

1 month

First QC Date

April 24, 2017

Last Update Submit

August 14, 2017

Conditions

Hearing Loss, Bilateral Sensorineural, Progressive

Outcome Measures

Primary Outcomes (1)

  • Usability (phone calls)

    The data, serving as primary outcomes are collected in a lab appointment. The participants will be asked to accept, reject and hang up phone calls with the aid of the push button of the hearing aid. The usability will be subjectively assessed by the participants and additionally by the investigators on given scales. Descriptive statistics will be executed. Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution. A significance level of 5% is pursued.

    One week

Secondary Outcomes (2)

  • Zero-defect performance in daily life

    Three weeks

  • Speech intelligibility in noise as signal to noise ratio in dB (dB SNR)

    One week

Study Arms (2)

Line extension of the Phonak Audéo B hearing aid

EXPERIMENTAL

The line extension of the Phonak Audéo B product family will be fitted to the participants individual hearing loss.

Device: Line extension of the Phonak Audéo B product family

Phonak Audéo B hearing aid

ACTIVE COMPARATOR

Phonak Audéo B will be fitted to the participants individual hearing loss.

Device: Phonak Audéo B

Interventions

Line extension of the Phonak Audéo B product familyDEVICE

The line extension of the Phonak Audéo B product family will be fitted to the participants individual hearing loss.

Line extension of the Phonak Audéo B hearing aid
Phonak Audéo BDEVICE

Phonak Audéo B will be fitted to the participants individual hearing loss.

Phonak Audéo B hearing aid

Eligibility Criteria

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

You may qualify if:

  • Adult hearing impaired persons (minimum age: 18 years) with and without (experience with) hearing aids
  • Good written and spoken (Swiss) German language skills
  • Healthy outer ear
  • Ability to fill in a questionnaire (p/eCRF) conscientiously
  • Informed Consent as documented by signature

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 in Stäfa (Switzerland)
  • 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
  • Central hearing disorders

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

Condition Hierarchy (Ancestors)

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

Study Officials

  • Simone Ebbing, B.Sc.

    Sonova AG

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Phonak Audéo B and a line extension of the Phonak Audéo B hearing aid product family will be fitted to the participants individual hearing loss.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2017

First Posted

April 27, 2017

Study Start

June 12, 2017

Primary Completion

July 18, 2017

Study Completion

July 18, 2017

Last Updated

August 17, 2017

Record last verified: 2017-08

Locations

CH(1)