Extended Wear Hearing Aid for Hearing Loss

Overseen By Study Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sonova AG

Disqualifiers: Vision impairment, Ear health conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

10 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will assess the benefit of extended wear hearing aids for subjective listening effort, compared to the unaided condition, in adults with mild sensorineural hearing loss.

Eligibility Criteria

Adults over 18 with mild sensorineural hearing loss, as defined by the WHO, who already use Lyric hearing instruments. Participants must understand English and be willing to follow study rules. Those with medical conditions needing referral before hearing aid fitting or ear health issues preventing device replacement cannot join.

Inclusion Criteria

Meets requirements outlined on Lyric Candidacy Form

I have mild hearing loss in my better ear.

Current Lyric hearing instrument user

Exclusion Criteria

I don't have any health issues that would prevent me from getting a hearing aid.

Does not meet requirements outlined on Lyric Candidacy Form (see Chapter 9 of the TMF/ISF for SRF-469)

Difficulty understanding/reading instructions when corrected for vision loss

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are fit with study Lyric devices and tested on speech intelligibility and effort using two different fitting algorithms

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

Treatment Details

Interventions

• Extended Wear Hearing Aid

Trial Overview The trial is testing if extended wear hearing aids reduce listening effort for adults with mild sensorineural hearing loss compared to not using a hearing aid at all. It measures subjective listening improvement in current users of these devices.

Participant Groups

Group I: Experimental Group Experimental Treatment 1 Intervention

Participants who are fit with study Lyric devices and tested on speech intelligibility and effort using two different fitting algorithms

Who Is Running the Clinical Trial?

Sonova AG

Lead Sponsor

Trials

84

Recruited

2,000+

Arnd Kaldowski

Sonova AG

Chief Executive Officer since 2018

MBA from INSEAD, MSc in Mechanical Engineering from ETH Zurich

Stefan Launer

Sonova AG

Chief Medical Officer since 2016

PhD in Natural Sciences from ETH Zurich

The Woodlands Hearing Center

Collaborator

Trials

1

Recruited

10+