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

NCT04496271 | Completed

• 1 other identifier: Sonova2020_06
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Rating sound quality of own voice

  5 weeks

• Evaluating listening effort

  5 weeks

Study Arms (2)

Successor of Phonak Audéo M-90

EXPERIMENTAL

Phonak Hearing aid with modified precalculation.

Device: RIC (Receiver in channel)- device

Phonak Audéo M-90

ACTIVE COMPARATOR

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

Interventions

RIC (Receiver in channel)- device DEVICE

HI is developed to support hearing impaired people in calm and complex situations and to be able to participate in communication

Phonak Audéo M-90; Successor of Phonak Audéo M-90

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sonova AG: lead

Study Sites (1)

Sonova AG

Stäfa, 8712, Switzerland

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: August 3, 2020
• Study Start: January 13, 2020
• Primary Completion: March 16, 2020
• Study Completion: April 8, 2020
• Last Updated: November 28, 2022

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)