NCT04723173

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

Completed NA Results posted Last updated 11 March 2022

What this trial tests

NA trial testing Feature for noise reduction (on) in Hearing Loss in 10 participants. Completed in 7 June 2021.

Timeline

7 December 2020

Primary endpoint
11 May 2021

7 June 2021

Quick facts

Lead sponsor	Sonova AG
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	other
Enrollment	10
Start date	7 December 2020
Primary completion	11 May 2021
Estimated completion	7 June 2021
Sites	1 location across Switzerland

Drugs / interventions tested

• Feature for noise reduction (on)
• Feature for noise reduction (off)

Conditions studied

• Hearing Loss — all drugs for Hearing Loss →

Sponsor

Sonova AG — full company profile →

Who can join

Adults 18 to 99, any sex, with Hearing Loss. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Subjective Listening Effort Scaling Primary · 2 weeks

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 d

Group	Value	95% CI
Noise Reduction on	-2.276	-4.91 – 0.358
Noise Reduction Off	-0.917	-3.55 – 1.717

Subjective Ratings of Speech and Music Samples (Part1: Sound Quality) Secondary · 4 weeks

The secondary Outcome measure of this study contains 2 parts. This first part reported here was the evaluation of the sound quality. A comparison was made between speech and music audio excerpts either with or without gain being increased by the feedback manager. Subjective ratings of sound quality were made under both of these conditions for one speech and one music sample, using the following scale: Bad (1) - Poor (2) - Fair (3) - Good (4) - Excellent (5). Results were analyzed separately for the speech and music samples.

Speech sample

Group	Value	95% CI
Evaluation of Sound Quality Without Increasing Gain	4	± 0.99
Evaluation of Sound Quality With Increasing Gain	4	± 1.16

Music sample

Group	Value	95% CI
Evaluation of Sound Quality Without Increasing Gain	3.5	± 1.49
Evaluation of Sound Quality With Increasing Gain	4	± 1.07

Measure of Detection Threshold (in dB) for Soft Sounds Secondary · 2 weeks

This outcome measure evaluated the ability to detect sounds in a quiet environment. A comparison was made between the feature under investigation being activated and deactivated. Participants were asked to change the level of a speech sample until they were just able to detect it. The ability will be measured by a detection threshold (in dB).

Group	Value	95% CI
Feature for Soft Noise on	36.62	± 8.1
Feature for Soft Noise Off	38.21	± 9.33

Subjective Ratings of Speech and Music Samples (Part 2: Artefact Perception) Secondary · 2 week

The second part of this secondary Outcome measure was the evaluation of audible artefacts either with or without the available gain being increased by the feedback manager. The outcome was measured as a binary response (artefacts audible/ not audible). Participants had to indicate whether artefacts were audible under both of these conditions. The number of positive ratings (artefacts were audible) was counted.

speech sample

Group	Value	95% CI
Feedback Management Off	2
Feedback Management on	1

music sample

Group	Value	95% CI
Feedback Management Off	1
Feedback Management on	1

Adverse events — posted to ClinicalTrials.gov

Time frame: 3.5 month. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Events During the Test Period

Serious: 0/9 (0%)

Deaths: 0/9

Events Prior to Test Period (After Screening Appointment and Signed Informed Consent Form)

Serious: 0/9 (0%)

Deaths: 0/9

Other adverse events (2 terms — click to expand)

Reaction	System	Events During the Test Per…	Events Prior to Test Perio…
Eye problem prior to first appointment	Eye disorders	—	—
Ear infection	Infections and infestations	—	—

Data from ClinicalTrials.gov NCT04723173 adverse events section.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.