Quality Control of CE-Certified Phonak Hearing Aids - 2020_26

Phonak Hearing Devices pass through different development and study phases. 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, resulting from the pre-validation studies, they get optimized. Prior to product launch, the Phonak Hearing Systems get reviewed by a final quality control in terms of clinical trials. This is a validation study, investigating improved algorithms, features, functions and wearing comfort. This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: RIC (Receiver in Canal) hearing aid/ hearing instrument (HI)

Detailed Description

This study will investigate the combination of the features to determine if the audiological performance and quality of the new successor of the Marvel family shows an improved benefit over Phonak Audéo Marvel before going into the System Validation. Therefore this study will be a comparative study. The study will determine if hearing impaired users wearing the successor hearing aids, have better initial acceptance with the new precalculation, better sound quality and speech intelligibility, more clarity and loudness comfort in soft and loud environments compared to Phonak Marvel RIC (Receiver in channel) hearing aids. Another objective of the study is to compare the listening effort with the two different study devices.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Stäfa, 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:

• Hearing Loss range: N3-N4
• experienced hearing aid user
• willingness to wear behind the ear hearing aids
• Informed Consent as documented by signature

Exclusion Criteria:

• the audiogram is not in the fitting range of the intended hearing aid
• first time user
• limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
• participant is not able to describe experiences and hearing impressions
• allergies against the material of the hearing aid

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Successor of Phonak Audéo M-90; Phonak Hearing instrument (HI) with modified precalculation.	Device: RIC (Receiver in Canal) hearing aid/ hearing instrument (HI); HI is developed to support hearing impaired people in calm and complex situations and to be able to participate in communication
Active Comparator: Phonak Audéo M-90; Phonak Audéo M-90 is the most recent RIC device from Phonak which will be fitted to the participants individual hearing loss.	Device: RIC (Receiver in Canal) hearing aid/ hearing instrument (HI); HI is developed to support hearing impaired people in calm and complex situations and to be able to participate in communication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rating of the sound quality for the new and the comparative HI	Subjective rating of the overall satisfaction for sound quality by questionnaires for the new HI and the old comparative HI (%). The participants rates after one week home trial. The home trial is randomized. The questionnaire includes rating scales for the satisfaction. The participant has to rate it in percentage (100% = very satisfy, 0% = very unsatisfy)	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech intelligibility in noisy situations (only test device)	Evaluating the speech intelligibility with the test device, using a speech in noise test, Oldenburger Satztest (OLSA) after the subject set the noise cancellation via an App on an individual limit. The results of the test are the word recognition score in SNR.	4 week
Speech intelligibility in quiet situations	Evaluating and comparing the speech intelligibility in a quiet test situation of the test device and the Marvel device. Using the "Reimtest nach Wallenberg und Kollmeier (WaKo ) (%).	4 week
Speech intelligibility in noisy situations	Evaluating and comparing the speech intelligibility in a noisy test situation of the test device and competitor. Using the OLSA (word recognition score)	4 weeks
Rating of sound quality	Subjective rating of the overall satisfaction for sound quality by questionnaires for the new HI and the old comparative HI (%). The participants rates after the First Fit. The questionnaire includes rating scales for the satisfaction. The participant has to rate it in percentage (100% = very satisfy, 0% = very unsatisfy)	1 week

Collaborators and Investigators

• Sponsor: Sonova AG

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): August 7, 2020
• Study Completion (Actual): August 7, 2020

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (Actual): August 3, 2020

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

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: Sonova2020_26

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No