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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well extended wear hearing aids reduce listening effort for individuals with mild hearing loss. Participants will use a special type of hearing aid, called Lyric, to determine if it eases speech comprehension compared to not using any aid. The trial targets adults who already use Lyric hearing aids and have mild sensorineural hearing loss, which slightly reduces their ability to hear certain frequencies. As an unphased trial, it offers participants the chance to contribute to understanding how Lyric hearing aids can enhance daily life for those with mild hearing loss.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this extended wear hearing aid is safe for adults with mild sensorineural hearing loss?

Past studies have proven the extended wear hearing aid, known as the Phonak Lyric, to be safe. Over 10 years of research and more than 320,000 fittings in 2017 demonstrate its effectiveness and safety. Reports indicate no serious issues, such as bleeding in the ear canal, even for users with conditions like diabetes.

While not entirely risk-free, risks can be reduced by following guidelines. It is important to have a professional fit the device and replace it when necessary. Overall, users generally tolerate the extended wear hearing aid well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The extended wear hearing aid is unique because it offers continuous, hassle-free hearing support without the need for daily insertion and removal, unlike traditional hearing aids. Researchers are excited about this device because it can be worn for extended periods, even during activities like sleeping and showering, potentially improving speech intelligibility and reducing listening effort. This means users can experience more natural hearing throughout their daily lives, which could significantly enhance their overall quality of life.

What evidence suggests that this extended wear hearing aid is effective for hearing loss?

Studies have shown that extended wear hearing aids can greatly enhance communication and satisfaction with hearing. For adults with hearing loss, regular use of hearing aids is linked to a lower risk of mortality compared to non-users. Research also indicates that these hearing aids can reduce the feeling of disadvantage due to hearing loss. Although extended wear hearing aids might not directly improve cognitive skills, mental health, or social life, they facilitate speech understanding and require less listening effort than not using any hearing aids. These findings suggest that extended wear hearing aids effectively manage mild hearing loss. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4730911/

Hearing aid use and long-term health outcomes There was no evidence that hearing aids promote cognitive function, mental health, or social engagement. Hearing aids may reduce hearing handicap and promote ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06746038

Evaluation of Extended Wear Hearing Aid for Mild ... This study will assess the benefit of extended wear hearing aids for subjective listening effort, compared to the unaided condition, in adults with mild ...

3. thelancet.com thelancet.com/journals/lanhl/article/PIIS2666-7568(23)00232-5/fulltext

Association between hearing aid use and mortality in ... Regular hearing aid use was associated with lower risks of mortality than in never users in US adults with hearing loss when accounting for age, hearing loss, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0020748925000598

Effects on health outcomes following a nurse-led hearing ... Conclusions. Significant improvements were seen in communication abilities and hearing aid satisfaction for older adults in the intervention group after ...

5. cureus.com cureus.com/articles/388093-the-international-outcome-inventory-for-hearing-aids-ioi-ha-and-its-correlation-with-world-health-organization-quality-of-life---brief-version-whoqol-bref-in-assessing-the-quality-of-life-of-patients-with-hearing-loss-using-hearing-aids

The International Outcome Inventory for Hearing Aids (IOI ... On the left side, 52 participants (24.8%) of the patients had severe hearing loss, or SNHL, in 145 cases (73.6%) of the instances, while 76 ...

6. phonakpro.com phonakpro.com/content/dam/phonakpro/gc_us/en/products_solutions/hearing_aid/lyric/documents/028-1834-03_Phonak_Lyric_Clinical_Insight_June_2019.pdf.

Phonak Lyric™ Clinical and Medical Review With over 10 years of clinical data monitoring, and more than 320,000. Lyric fittings in 2017, Lyric has continued to show that it's a safe and effective.

7. hearingreview.com hearingreview.com/practice-building/practice-management/real-world-safety-experience-with-a-247-hearing-device

Real-World Safety Experience with a 24/7 Hearing Device They did not experience any bleeding problems in the ear canal. There were 12 patients with diabetes in the group of 300 who wore Lyric for more than 1 month.

8. phonak.com phonak.com/content/dam/phonak/en/evidence-library/field-studies/fsn_lyric_safety_jun2011.pdf

A study on the safety of Lyric and user satisfaction Lyric is a safe hearing aid. Like any other hearing aid, it is not completely risk-free, but these risks can be minimized by adhering to all of ...

9. hearingandaudiology.com.au hearingandaudiology.com.au/blog/pros-and-cons-of-lyric-hearing-aids/

Pros and Cons of Lyric Hearing Aids | Comprehensive Guide Higher cost compared to traditional hearing aids · Requires professional fitting and regular replacements · Limited suitability for those with severe hearing loss ...

10. sussexaudiologycentre.co.uk sussexaudiologycentre.co.uk/are-there-any-potential-side-effects-or-risks-associated-with-using-phonak-lyric-hearing-aid/

Are there any potential side effects or risks associated with ... Discover potential side effects or risks associated with using Phonak Lyric Hearing Aid in our informative blog post, providing insights to ...