Quality Control of CE-Certified Phonak Hearing Aids - 2017_13

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss, Bilateral Sensorineural, Progressive
• Intervention / Treatment: Device: Line extension of the Phonak Audéo B product family; Device: Phonak Audéo B

Detailed Description

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. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials in the way as planned for this study ("phase of final inspection"). This will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zürich
    • Stafa, Zürich, Switzerland, 8712
      • Sonova AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Line extension of the Phonak Audéo B hearing aid; 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; The line extension of the Phonak Audéo B product family will be fitted to the participants individual hearing loss.
Active Comparator: Phonak Audéo B hearing aid; Phonak Audéo B will be fitted to the participants individual hearing loss.	Device: Phonak Audéo B; Phonak Audéo B will be fitted to the participants individual hearing loss.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Zero-defect performance in daily life	The data, serving as secondary outcomes are collected in a series of home trials taking place between the lab trial appointments. The zero-defect performance in daily life (that means: no interruptions, distortions, artefacts, feedback, system noise or other malfunctions) will be assessed with the aid of quantitative questionnaires. The results are "Yes/No" replies and open-ended.	Three weeks
Speech intelligibility in noise as signal to noise ratio in dB (dB SNR)	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 Oldenburg sentence test. The result is the signal to noise ratio in dB (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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2017
• Primary Completion (Actual): July 18, 2017
• Study Completion (Actual): July 18, 2017

Study Registration Dates

• First Submitted: April 24, 2017
• First Submitted That Met QC Criteria: April 24, 2017
• First Posted (Actual): April 27, 2017

Study Record Updates

• Last Update Posted (Actual): August 17, 2017
• Last Update Submitted That Met QC Criteria: August 14, 2017
• Last Verified: August 1, 2017

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; Hearing Loss, Bilateral
• Other Study ID Numbers: Sonova2017_13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No