Quality Control of CE-Certified Phonak Hearing Aids - 2017_27

NCT03253003 | Completed

• 1 other identifier: Sonova2017_27
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of participants with a hearing loss to grant quality control prior to product launch. The aim of the investigation series is to ensure a stable overall performance of the new hearing systems, a good sound quality during phone calls as well as maximum benefit for the participant with the devices.

Conditions

Hearing Loss, Bilateral Sensorineural, Progressive

Outcome Measures

Primary Outcomes (2)

• Stable performance in daily life

  The data, serving as primary outcomes are collected in a series of home trials, taking place between the lab trial appointments. The stable performance in daily life (that means: no significant interruptions, distortions, artefacts, feedback, system noise or other malfunctions) will be assessed with the aid of quantitative questionnaires. Descriptive statistics will be executed. Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution. A significance level of 5% is pursued.

  Three weeks

• Phone call - Sound Quality

  The data serving as primary outcomes are collected in a lab appointment. The participants will be asked to have a phone call with the investigator in the lab. The sound quality will be subjectively assessed by the participants and additionally by the investigators on given scales. Descriptive statistics will be executed. Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution. A significance level of 5% is pursued.

  One week

Study Arms (1)

Audéo B hearing aid line extension

EXPERIMENTAL

The line extension of the Phonak Audéo B product family will be fitted to the participants individual hearing loss.

Device: Line extension of the Phonak Audéo B product family

Interventions

Line extension of the Phonak Audéo B product family DEVICE

The line extension of Phonak Audéo B product family will be fitted to the participants individual hearing loss.

Audéo B hearing aid line extension

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) with and without (experience with) hearing aids
• Good written and spoken (Swiss) German language skills
• Healthy outer ear
• Ability to fill in a questionnaire (p/eCRF) conscientiously
• Informed Consent as documented by signature
• Smartphone user

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
• Massively limited dexterity
• 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

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 Officials

• Simone Ebbing, B. Sc.

  Sonova AG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A line extension of the Phonak Audéo B hearing aid product family will be fitted to the participants individual hearing loss.

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 17, 2017
• Study Start: August 7, 2017
• Primary Completion: August 25, 2017
• Study Completion: August 25, 2017
• Last Updated: September 25, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)