NCT02754843

Brief Summary

The purpose of this study, which contains a series of successive study parts, is to methodically evaluate Phonak Hearing Systems on hard of hearing participants to grant quality control prior to each product launch.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
Last Updated

April 28, 2016

Status Verified

April 1, 2016

Enrollment Period

3 months

First QC Date

October 16, 2015

Last Update Submit

April 25, 2016

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (2)

  • Speech intelligibility in quiet. Discrimination [%]

    The data, serving as primary outcome, are collected in a series of lab appointments. The speech intelligibility in quiet will be assessed with the aid of the German rhyme test "Einsilber-Reimtest nach von Wallenberg und Kollmeier" (WaKo). The result is the speech intelligibility in percent. Descriptive statistics will be executed in the form of determining the median and quartiles. 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.

  • Speech intelligibility in noise. Speech Reception Threshold [dB SNR]

    The data, serving as primary outcome, are collected in a series of lab appointments. The speech intelligibility in noise will be assessed with the aid of the German Oldenburger sentence test. The result is the Speech Reception Threshold \[dB SNR\]. Descriptive statistics will be executed in the form of determining the median and quartiles. 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 (4)

  • Phoneme Perception Test, test no. 1.

    Four weeks

  • Phoneme Perception Test, test no. 2.

    Four weeks

  • Phoneme Perception Test, test no. 3.

    Four weeks

  • Diary to describe hearing impressions in everyday life

    Six weeks

Study Arms (2)

Naida Q90-SP

ACTIVE COMPARATOR

Phonak's commercial power Behind-The-Ear (BTE) device, type 1.

Device: Phonak's equivalent newly developped power BTEDevice: Equivalent competitor device

Naida Q90-UP

ACTIVE COMPARATOR

Phonak's commercial power Behind-The-Ear (BTE) device, type 2.

Device: Phonak's equivalent newly developped power BTEDevice: Equivalent competitor device

Interventions

Phonak's equivalent newly developped power BTEDEVICE
Naida Q90-SPNaida Q90-UP
Equivalent competitor deviceDEVICE
Naida Q90-SPNaida Q90-UP

Eligibility Criteria

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

You may qualify if:

  • Hearing impaired persons with and without (experience with) hearing aids
  • Good written and spoken (Swiss) German language skills
  • Healthy outer ear (without previous surgical procedures)
  • Ability to fill in a questionnaire conscientiously
  • Informed Consent as documented by signature

You may not qualify if:

  • Contraindications to the medical device 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
  • 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 Zürich, 8635, 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
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2015

First Posted

April 28, 2016

Study Start

October 1, 2015

Primary Completion

January 1, 2016

Last Updated

April 28, 2016

Record last verified: 2016-04

Locations

CH(1)