Quality Control of CE-Labelled Phonak Hearing Systems (Study Part: Sonova2015-00)

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Phonak's equivalent newly developped power BTE; Device: Equivalent competitor device

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Canton Zürich
    • Stäfa, Canton Zürich, Switzerland, 8635
      • Sonova AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Naida Q90-SP; Phonak's commercial power Behind-The-Ear (BTE) device, type 1.	Device: Phonak's equivalent newly developped power BTE; Device: Equivalent competitor device
Active Comparator: Naida Q90-UP; Phonak's commercial power Behind-The-Ear (BTE) device, type 2.	Device: Phonak's equivalent newly developped power BTE; Device: Equivalent competitor device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phoneme Perception Test, test no. 1.	Free field audiometry using narrow band high frequency signals to measure detection thresholds [dB]. 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.	Four weeks
Phoneme Perception Test, test no. 2.	Free field audiometry using high frequency phonemes to capture their recognition thresholds [dB]. 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.	Four weeks
Phoneme Perception Test, test no. 3.	Free field audiometry using high frequency phonemes to capture the subjects' distinction capabilities [confusion matrix]. 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.	Four weeks
Diary to describe hearing impressions in everyday life	Subjects are asked to describe their subjective experiences in different listening situations, in daily life, with the aid of quantitative questionnaires. the results are "Yes/No" replies and open-ended.	Six weeks

Collaborators and Investigators

• Sponsor: Sonova AG
• Investigators: Principal Investigator: Simone Ebbing, B.Sc., Sonova AG

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: October 16, 2015
• First Submitted That Met QC Criteria: April 25, 2016
• First Posted (Estimate): April 28, 2016

Study Record Updates

• Last Update Posted (Estimate): April 28, 2016
• Last Update Submitted That Met QC Criteria: April 25, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: Sonova2015-00