Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2020_09

NCT ID: NCT04578457

Last Updated: 2021-10-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-23

Study Completion Date

2021-04-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Participants will perform two different listening tasks: (1) listening to, and repeating back, sentence lists presented in noise, and (2) Subjective rating of effort \& performance following each condition. During this study, continuous, non-invasive physiological measurements (skin conductance, changes in pupil dilation) will be recorded from participants. Using this paradigm we will be assessing the effect of different hearing aid processing algorithms on listening effort. The study takes the form of a one factor (algorithm), within-subjects design.

Each participant performs the Speech perception task with each algorithm (reference, noise reduction I, noise reduction II, noise reduction III), at two individualized signal-to-noise ratios (SRT90 and SRT50). Additionally subjective performance ratings in real-life will be collected.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hearing Loss

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hearing Aid without NR(0) enabled

Hearing Aid without Noise Reduction (NR 0) enabled serves as reference condition.

Group Type ACTIVE_COMPARATOR

Hearing Aid without NR enabled

Intervention Type DEVICE

Each participant will be fitted with noise reduction disabled. Disabled means that no sound processing algorithm that removes noise from the speech signal is active.

Hearing Aid with NR (1)

Hearing Aid with Noise Reduction I (NR) enabled.

Group Type EXPERIMENTAL

Hearing Aid with NR(1)

Intervention Type DEVICE

Each participant will be fitted with the noise reduction program on the same hearing aid. The principle of the noise reduction algorithm is to remove noise from a speech signal with the aim of improving the speech intelligibility and comfort.

Hearing Aid with NR(2)

Hearing Aid with Noise Reduction II (NR) enabled.

Group Type EXPERIMENTAL

Hearing Aid with NR(2)

Intervention Type DEVICE

Each participant will be fitted with a second noise reduction program on the same hearing aid. The parameterization of this NR algorithm differs from that in NR(1).

Hearing Aid with NR(3)

Hearing Aid with Noise Reduction III (NR) enabled.

Group Type EXPERIMENTAL

Hearing Aid with NR(3)

Intervention Type DEVICE

Each participant will be fitted with a third noise reduction program on the same hearing aid. The parameterization of this NR algorithm differs from that in NR(1) and NR(2).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hearing Aid without NR enabled

Each participant will be fitted with noise reduction disabled. Disabled means that no sound processing algorithm that removes noise from the speech signal is active.

Intervention Type DEVICE

Hearing Aid with NR(1)

Each participant will be fitted with the noise reduction program on the same hearing aid. The principle of the noise reduction algorithm is to remove noise from a speech signal with the aim of improving the speech intelligibility and comfort.

Intervention Type DEVICE

Hearing Aid with NR(2)

Each participant will be fitted with a second noise reduction program on the same hearing aid. The parameterization of this NR algorithm differs from that in NR(1).

Intervention Type DEVICE

Hearing Aid with NR(3)

Each participant will be fitted with a third noise reduction program on the same hearing aid. The parameterization of this NR algorithm differs from that in NR(1) and NR(2).

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy outer ear (without previous surgical procedures)
* Ability to fill in a questionnaire conscientiously
* Informed Consent as documented by signature
* Minimum 1 year hearing aid experience
* Moderate-Severe (N3-N5) hearing loss or Normal Hearing

Exclusion Criteria

* 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
* Inability to produce a reliable hearing test result
* Massively limited dexterity
* Known psychological problems
* Known central hearing disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sonova AG

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sonova AG

Stäfa, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Sonova2020_09

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Evaluation of Hearing Aid Benefit
NCT05198713 COMPLETED NA