NCT03086018 is a NA clinical trial of Successor hearing aid to Juna in Hearing Loss, sponsored by Bernafon AG.

Who is sponsoring NCT03086018?

NCT03086018 is sponsored by Bernafon AG.

What drugs are being tested in NCT03086018?

Interventions in NCT03086018: Successor hearing aid to Juna.

What condition does NCT03086018 study?

NCT03086018 studies Hearing Loss.

Is NCT03086018 still recruiting?

NCT03086018 is currently completed. Last updated 6 November 2019.

Are results published for NCT03086018?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-11-06 · How we verify

NCT03086018

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Comparative, Controlled, Clinical Investigation and Quality Control of a New Hearing Aid

Completed NA Results posted Last updated 6 November 2019

What this trial tests

NA trial testing Successor hearing aid to Juna in Hearing Loss in 30 participants. Completed in 28 June 2017.

Timeline

13 March 2017

Primary endpoint
28 June 2017

28 June 2017

Quick facts

Lead sponsor	Bernafon AG
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	13 March 2017
Primary completion	28 June 2017
Estimated completion	28 June 2017
Sites	1 location across Switzerland

Drugs / interventions tested

Successor hearing aid to Juna

Conditions studied

Hearing Loss — all drugs for Hearing Loss →

Sponsor

Bernafon AG

Who can join

18 and older, 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.

Speech Intelligibility Performance Primary · 2 hour period of speech testing during a lab appointment after wearing the devices for approximately 2 weeks.

Speech test scores will be measured with speech reception thresholds (SRTs) of speech in noise in three conditions: unaided, aided with the current device, and aided with the new device. The score is measured by the the signal-to-noise ratio (SNR) at which 50% of words in a sentence list are correctly repeated. The speech is always presented at 65 dB and the background noise varies to maintain the 50% correct. A lower SNR score indicates a better score. The maximum score will be 15 dB and the minimum will be -5 dB.

Unaided

Group	Value	95% CI
Successor Hearing Aid to Juna	-1.25	± 1.45

Aided with current device

Group	Value	95% CI
Successor Hearing Aid to Juna	-3.89	± 0.99

Adided with new device

Group	Value	95% CI
Successor Hearing Aid to Juna	-5.22	± 1.09

Subjective Performance of Aided Benefit Secondary · A 2 week time period during which they will wear the devices and answer questionnaires about the experience.

The subjective performance for the new device will be measured with the APHAB questionnaire (Abbreviated Hearing Aid Benefit Profile). The questionnaire is a list of 24 statement that the subjects must agree or disagree with using a scale of units from A to G (A being Always and G being Never). Each letter has a corresponding score used for the calculation: A receives 99, B receives 87, C receives 75, D receives 50, E receives 25, F recevies 12, and G receives 1. An average for each subscale is calculated, and a global or overall score can be calculated by taking the mean of the three positiv

Ease of Communication

Group	Value	95% CI
Experimental: Successor Hearing Aid to Juna	37.38	± 24.11

Background Noise

Group	Value	95% CI
Experimental: Successor Hearing Aid to Juna	44.29	± 16.89

Reverberation

Group	Value	95% CI
Experimental: Successor Hearing Aid to Juna	42.08	± 23.96

Aversiveness

Group	Value	95% CI
Experimental: Successor Hearing Aid to Juna	-17.63	± 26.14

Global Score

Group	Value	95% CI
Experimental: Successor Hearing Aid to Juna	40.30	± 20.49

Speech Intelligibility Performance With New Feature Secondary · 2 hour period of speech testing during a lab appointment after wearing the devices for approximately 2 weeks.

Word recognition test scores will be measured with two signal-to-noise ratio (SNR) levels in percent correct in two conditions, with the new feature on and the new feature off. The test is a speech test with the words stated in noise at either a 5 dB SNR or a 15 dB SNR. The subject is presented with 5 rhyming words and must choose which word they heard. It is a forced choice meaning that the test will not continue with the next word until they've made a selection. They cannot leave any blank and are not penalized for wrong answers. The score is a percentage of words correct with the maximum s

+5 SNR WAKO Feature on

Group	Value	95% CI
Experimental: Successor Hearing Aid to Juna	73.5	± 5.2

+5 SNR WAKO Feature off

Group	Value	95% CI
Experimental: Successor Hearing Aid to Juna	73.7	± 4.95

+15 SNR WAKO Feature on

Group	Value	95% CI
Experimental: Successor Hearing Aid to Juna	87.27	± 4.08

+15 SNR WAKO Feature off

Group	Value	95% CI
Experimental: Successor Hearing Aid to Juna	88.1	± 4.63

Handling/Usability Performance Secondary · 2 hour period of usability testing with tasks and questionnaires.

The usability of the new device will be measured with a 3-point rating scale used by the tester to evaluate tasks performed by the end user as well as questionnaires and interviews. The questionnaire asks subjects to perform tasks, and the clinician rates the ease with which they complete the tasks. 2 is the highest score meaning that they could complete without help, 1 means that they required some assistance, and 0 means that they could not complete the task. A higher score means a better outcome.

Group	Value	95% CI
Experimental: Successor Hearing Aid to Juna	97

Events Secondary · A 2 hour period of interviews and questionnaires after having worn the devices for approximately 2 weeks and keeping a diary to make notes of device behavior.

Events will be measured by the reporting of unexpected sounds or behavior of the device through questionnaires, diaries, and interviews. The number of events reported including AEs related to the device will be used to measure the outcome. Less events is a better outcome.

Group	Value	95% CI
Experimental: Succssor Hearing Aid to Juna	4

Adverse events — posted to ClinicalTrials.gov

Time frame: 4 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Experimental: Successor Hearing Aid to Juna

Serious: 1/30 (3%)

Deaths: 0

Serious adverse events (1 terms)

Reaction	System	Experimental: Successor He…
Hospitalization due to accident	Social circumstances	—

Other adverse events (12 terms — click to expand)

Reaction	System	Experimental: Successor He…
Cold	General disorders	—
Tore Meniscus	General disorders	—
Scratch on ear canal	General disorders	—
Dome in Ear	Product Issues	—
Headache	General disorders	—
Irritation in ear	General disorders	—
Sore Concha	Product Issues	—
Back Pain	General disorders	—
Pressure point	General disorders	—
Tore Groin muscle	General disorders	—
Leg problem	General disorders	—
Face Swelling	General disorders	—

Most-reported serious reactions: Hospitalization due to accident.

Data from ClinicalTrials.gov NCT03086018 adverse events section.

Sponsor's own description

The aim of this study is to investigate the performance of the hearing aid under laboratory as well as everyday conditions. In addition, the performance data of the hearing aid are compared with a Bernafon hearing aid already available on the market. The hearing aids are adapted according to the user requirements. The data collected in the study is intended to show that the benefit of the hearing aid being examined is identical or better than the current CE-marked hearing aid. A further aim is to improve the adaptation of the hearing device in such a way that the benefit for people with hearing impairments can be increased.

Publications & conference data

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

Verify or expand the search:

Other recruiting trials for Hearing Loss

Currently open trials in the same condition.

NCT07176936 — Improving Speech in Noise Using Noninvasive Stimulation · NA · recruiting
NCT07506408 — Randomised Study of Web-Based Auditory Training With Varying Perceptual and Cognitive Demands on Training Gains and Gene · NA · recruiting
NCT07218913 — Testing the Addition of Pedmark to Cisplatin Chemotherapy for Reducing Drug-Induced Ear Damage in Men With Stage II-III · Phase 1 · recruiting
NCT07414329 — Efficacy and Effectiveness of an Investigational Behind-the-Ear Hearing Device Kit · NA · recruiting
NCT06930560 — HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms · NA · recruiting

Other Bernafon AG trials

Trials by the same sponsor.

NCT04939259 — A Comparative Clinical Investigation of Musician's Preference With Hearing Aids · NA · completed
NCT04374851 — A Comparative Clinical Investigation of Two Hearing Instrument Digital Signal Processing · NA · completed
NCT04147442 — A Standard Music Program Compared to an Optimized Music Program · NA · completed
NCT04146272 — A Comparison of a New Acoustic Feedback Canceller in Hearing Aids With the Current System · NA · completed
NCT04168229 — A Clinical Investigation of the Benefit: BTE Hearing Aids Versus ITE Hearing Aids · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03086018 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bernafon AG
Last refreshed: 6 November 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03086018.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing