Quality Control of CE-Certified Phonak Hearing Aids - 2018_42

NCT03938753 | Completed

• 1 other identifier: Sonova2018_42
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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. This is a pre-validation study, investigating optimized algorithms, features, functions and wearing comfort. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Conditions

Hearing Loss; Sensorineural Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Subjective perception of the T-Coil Sound Quality

  The primary objective of this study is to measure that the overall sound Quality of the T-Coil program \[subjective satisfaction rating on a scale from 0%-100% in 1% steps\] of the investigational device is rated as at least as 60% or better \[60% is the border between 'ok' and 'satisfied'\] after a test period with daily life situations.

  4 weeks

Secondary Outcomes (1)

• Program switch-back workflow into T-Coil program

  4 weeks

Other Outcomes (3)

• Observation of the system stability

  4 weeks

• Sound Quality rating of T-Coil program under lab conditions

  4 weeks

• Subjective perception of audio artefacts in T-Coil program

  4 weeks

Study Arms (1)

Phonak Audéo M90-T

EXPERIMENTAL

The Phonak Audéo M90-T is a Receiver-in-the-canal Hearing aid with direct connectivity functionality and a T-Coil from Phonak which will be fitted to the participants individual Hearing loss.

Device: Audéo M90-T

Interventions

Audéo M90-T DEVICE

Receiver in the canal (RIC) Hearing aid form Phonak which will be fitted to the participants individual Hearing loss.

Phonak Audéo M90-T

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult hearing impaired persons (minimum age: 18 years, moderate to severe Hearing loss)
• Good written and spoken (Swiss) German language skills
• Healthy outer ear
• Ability to fill in a questionnaire (p/eCRF) conscientiously
• Willingness to wear Receiver in the canal hearing aids
• Informed Consent as documented by signature
• Owning a compatible smartphone

You may not qualify if:

• 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
• Known psychological problems
• Central hearing disorders

Sponsors & Collaborators

• Sonova AG: lead

Study Sites (1)

Sonova AG

Stäfa, Canton of Zurich, 8712, Switzerland

Location

MeSH Terms

Conditions

Hearing Loss; Hearing Loss, Sensorineural

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 6, 2019
• Study Start: January 9, 2019
• Primary Completion: February 7, 2019
• Study Completion: February 28, 2019
• Last Updated: May 6, 2019

Record last verified: 2019-05

Locations

CH (1)