UnknownNot Applicable

Effect of Speech Enhancer on Listening Effort With EEG

Germany27 participantsStarted 2023-10-16

Plain-language summary

In previous studies, Speech Enhancer has been shown to improve Listening Effort using a subjective method. To overcome the weakness of subjective testing, this study uses an objective measurement that has shown convincing results in previous studies addressing Listening Effort.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Experienced (minimum use duration 6 months) * Adult (minimum age: 18 years) hearing aid users, * Symmetrical hearing loss (difference between ears \<= 10 dB for 1kHz-6kHz), * Sensorineural hearing loss, * Air Conduction - bone conduction gap \<= 10 dB, * Written and spoken German, * Ability to understand instruction, * Ability to describe listening experiences, * Ability to attend to the appointments, * Healthy outer ear (without previous surgical proce-dures), * Hearing loss within the fitting ranges of the investiga-tional product, * Informed consent as documented by signature. Exclusion Criteria: * Clinical contraindications deformity of the ear (closed ear canal or absence of pinna), * Known hypersensitivity or allergy, * Not willing to wear the hearing aid, * Fluctuating hearing that could influence the results, * Limited mobility and not in the position to attend all appointments, * Inability to produce a reliable hearing test result, * Massively limited dexterity, * Known psychological problems, * Known central hearing disorders.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

EEG alpha power measured during Listening Effort Task (LET)

Timeframe: 10 weeks

Trial details

NCT IDNCT06049199

SponsorSonova AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-22

View on ClinicalTrials.gov More Listening Effort trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.