Quality Control of CE-Certified Phonak Hearing Aids - 2020_06

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 channel)- device

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): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Stäfa, Switzerland, 8712
    • Sonova AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Self-reported confidence to using Bluetooth smartphone
• Hearing Loss range: moderate and moderate/ severe
• experienced hearing aid user
• willingness and interest in testing new features
• 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
• limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
• participant is not able to describe experiences and hearing impressions
• participant has finger movement disorders

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 aid with modified precalculation.	Device: RIC (Receiver in channel)- device; 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 Receiver In Canal hearing aid by Phonak which will be fitted to the participants individual hearing loss.	Device: RIC (Receiver in channel)- device; 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 Hearing aid	Subjective rating of the overall satisfaction for sound quality by questionnaires for the new HI and the old comparative HI (%). The questionnaire includes rating scales for the satisfaction. The participant has to rate it in percentage (100% = very satisfy, 0% = very unsatisfy)	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rating sound quality of own voice	Evaluating subjectively the HI regarding to the naturalness of the own voice. Participant will be ask in the first visit for spontaneous acceptance, regarding to the quality of their own voice, by rating scales. They have to rate the clarity, dullness etc. of their own voice. Also they will be ask after the hometrial how satisfy they are with the sound quality of their own voice.They have to rate it by rating scales in percentage. (e.g. very satisfy = 100%, very unsatisfy = 0%)	5 weeks
Evaluating listening effort	Evaluating listening effort by a special feature. The participants will be in a noisy test situation and have to listen to words, which they should repeat. After each group of words they will be ask to rate how difficult it was to understand by a rating scala (very difficult-difficult-somewhat-easy-very easy). The participants have to do that with the new and the old RIC device. The test will be randomized and single blinded.	5 weeks

Collaborators and Investigators

• Sponsor: Sonova AG

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2020
• Primary Completion (Actual): March 16, 2020
• Study Completion (Actual): April 8, 2020

Study Registration Dates

• First Submitted: February 28, 2020
• First Submitted That Met QC Criteria: July 31, 2020
• First Posted (Actual): August 3, 2020

Study Record Updates

• Last Update Posted (Actual): November 28, 2022
• Last Update Submitted That Met QC Criteria: November 24, 2022
• Last Verified: April 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_06

Plan for Individual participant data (IPD)

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

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