Quality Control of CE-Certified Phonak Hearing Aids - 2015_03

Quality Control of CE-Certified Phonak Hearing Aids

Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Hearing Aid (Phonak Audéo V90-13); Device: Hearing Aid (Successor of Phonak Audéo V90-13)

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zürich
    • Stäfa, Zürich, Switzerland, 8712
      • 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:

• 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

Exclusion Criteria:

• 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
• Massively limited dexterity
• Known psychological problems
• Central hearing disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Phonak Audéo V90-13; The Phonak Audéo V90-13 will be fitted to the participants individual hearing loss.	Device: Hearing Aid (Phonak Audéo V90-13); Phonak's Receiver-In-the-Canal (RIC) hearing aid Audéo V90-13 will be fitted to the participants individual Hearing loss.
EXPERIMENTAL: Successor of Phonak Audéo V90-13; The successor of Phonak Audéo V90-13 will be fitted to the participants individual hearing loss.	Device: Hearing Aid (Successor of Phonak Audéo V90-13); The successor of Phonak's Receiver-In-the-Canal (RIC) hearing aid Audéo V90-13 will be fitted to the participants individual Hearing loss.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech intelligibility in percent in a quiet listening situation	The data, serving as primary outcomes 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech intelligibility in percent in a noisy listening situation	The data, serving as secondary outcomes are collected in a series of lab appointments. The speech intelligibility in noise 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initial first fit acceptance (pre-calulation) in lab	The data, serving other pre-specified outcomes are collected within the first lab appointment. The acceptance of the initial first fit will be assessed with the aid of quantitative questions within an interview. The results are points on a scale and open ended (e.g. Question: Please rate the sound quality; Answer scale: bad, poor, fair, good, excellent) . Descriptive statistics will be executed in the form of determining number of answers. 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
Sound quality and listening effort ratings in lab	The data, serving other pre-specified outcomes are collected within the lab appointments. The sound quality and listening effort ratings will be assessed with the aid of the Multi-Stimulus Test with Hidden Reference and Anchor (MUSHRA). The results are quantitative sound quality and listening effort ratings. 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

Collaborators and Investigators

• Sponsor: Sonova AG

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (ACTUAL): January 1, 2016
• Study Completion (ACTUAL): February 1, 2016

Study Registration Dates

• First Submitted: March 31, 2016
• First Submitted That Met QC Criteria: April 11, 2016
• First Posted (ESTIMATE): April 15, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 21, 2018
• Last Update Submitted That Met QC Criteria: June 20, 2018
• Last Verified: June 1, 2018

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_03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO