Quality Control of CE-Certified Phonak Hearing Aids - 2020_43

NCT04723173 | Completed Results

• 1 other identifier: Sonova2020_43
• Study Type: interventional
• Target: 10
• 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 investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Subjective Listening Effort Scaling

  A listening effort scaling procedure ('ACALES'; Krueger et al, 2017) was performed with noise cancellation on and off. ACALES is adaptive, altering the signal-to-noise ratio (SNR) at which speech is presented. Therefore it is not a simple rating scale. For each stimulus, a rating (14-point scale ranging from 1='effortless' to 14= 'only noise') was given for how "effortful" it was following speech. This results in 2-D data: a list of presentation SNRs (different for each participant), and respective participant ratings. Given the format of this data, it cannot be summarized using standard descriptive statistics. We defined SNR as the dependent variable and fitted a linear mixed effects model, with the predictors: listening effort rating \& intervention (treating participants as a random factor), characterizing SNR over the entire rating scale. The values reported represent the estimated marginal means of SNR for each intervention, averaged across effort ratings \& participants.

  2 weeks

Secondary Outcomes (3)

• Subjective Ratings of Speech and Music Samples (Part1: Sound Quality)

  4 weeks

• Measure of Detection Threshold (in dB) for Soft Sounds

  2 weeks

• Subjective Ratings of Speech and Music Samples (Part 2: Artefact Perception)

  2 week

Study Arms (2)

Experimental device: Noise reduction on

EXPERIMENTAL

The noise reduction is activated. The feature shall support the hearing aid user in noisy situation and shall reduce the listening effort in these special situations.

Device: Feature for noise reduction (on)

Experimental device: Noise reduction off

ACTIVE COMPARATOR

To compare the advantage of the special noise reduction feature the tests will be done additionally with the deactivated feature.

Device: Feature for noise reduction (off)

Interventions

Feature for noise reduction (on) DEVICE

The noise reduction feature shall support the hearing aid user in noisy situations and shall reduce the listening effort.

Experimental device: Noise reduction on

Feature for noise reduction (off) DEVICE

To show the advantage of the noise reduction feature there is a comparison without the feature necessary.

Experimental device: Noise reduction off

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, severe to profound 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 Behind-the-ear hearing aids
• Informed Consent as documented by signature

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

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

Results Point of Contact

• Title: Bernhard Buschle
• Organization: Sonova AG

bernhard.buschle@sonova.com

+41 58 928 44 21

Publication Agreements

• PI is Sponsor Employee: Yes

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: January 22, 2021
• First Posted: January 25, 2021
• Study Start: December 7, 2020
• Primary Completion: May 11, 2021
• Study Completion: June 7, 2021
• Last Updated: March 11, 2022
• Results First Posted: February 17, 2022

Record last verified: 2021-08

Locations

CH (1)