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

NCT04496791 | Completed

• 1 other identifier: Sonova2020_26
• Study Type: interventional
• Target: 24
• 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 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 Outcomes (4)

• Speech intelligibility in noisy situations (only test device)

  4 week

• Speech intelligibility in quiet situations

  4 week

• Speech intelligibility in noisy situations

  4 weeks

• Rating of sound quality

  1 week

Study Arms (2)

Successor of Phonak Audéo M-90

EXPERIMENTAL

Phonak Hearing instrument (HI) with modified precalculation.

Device: RIC (Receiver in Canal) hearing aid/ hearing instrument (HI)

Phonak Audéo M-90

ACTIVE COMPARATOR

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)

Interventions

RIC (Receiver in Canal) hearing aid/ hearing instrument (HI) 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: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hearing Loss range: N3-N4
• experienced hearing aid user
• 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
• 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

Sponsors & Collaborators

• Sonova AG: lead

Study Sites (1)

Sonova AG

Stäfa, 8712, Switzerland

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Root Canal Therapy; Hearing Aids

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry; Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids

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: July 29, 2020
• First Posted: August 3, 2020
• Study Start: June 1, 2020
• Primary Completion: August 7, 2020
• Study Completion: August 7, 2020
• Last Updated: September 10, 2020

Record last verified: 2020-09

Locations

CH (1)