Hearing Aid Programs for Hearing Loss

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sonova AG

Disqualifiers: Unilateral hearing loss, 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 find the best hearing aid settings to improve speech understanding for people with hearing loss. Participants will test hearing aids with three different settings to determine which works best. The goal is to measure how well participants understand speech with each setting. Individuals with moderate to severe hearing loss in both ears who are accustomed to wearing hearing aids may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to refine hearing aid technology for better speech comprehension.

Do I need to stop 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 these hearing aid programs are safe for hearing loss?

Research has shown that Phonak Audeo RIC hearing aids are safe to use. Product information indicates they are expected to work well for up to five years, allowing users to comfortably rely on them during this period. Similar safety results have been observed in other models, such as the Audéo Marvel and Audéo Paradise. No major negative side effects have been reported from using these devices.

Overall, the evidence suggests these hearing aids are reliable and safe for everyday use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Phonak Audeo RIC hearing aids because they offer a versatile approach to managing hearing loss. Unlike traditional hearing aids, which typically use a single preset program, the Audeo RIC devices are programmed with three different settings, allowing for a more tailored listening experience. This adaptability means users can customize their hearing aids based on various environments, potentially leading to improved hearing outcomes and user satisfaction. This trial is all about understanding how these different settings can enhance the effectiveness of hearing aids, which could represent a significant advancement over existing options.

What evidence suggests that these hearing aid programs are effective for improving speech intelligibility in hearing loss?

Studies have shown that Phonak Audeo RIC hearing aids greatly help people understand speech, especially those with hearing difficulties. Research indicates that these hearing aids improve the ability to separate speech from background noise, making it easier to hear in noisy places. They effectively assist people with mild to severe hearing loss, providing the expected benefits. Overall, evidence supports their ability to enhance hearing and speech clarity. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals with bilateral deafness or hearing loss who can use Phonak Audeo Infinio Hearing Aids. Participants will be tested on speech intelligibility using three different hearing aid settings. The specific eligibility criteria are not provided, so general conditions related to hearing impairment apply.

Inclusion Criteria

Fluent in English

Experienced hearing aid user

I can understand and respond to complex instructions.

Exclusion Criteria

New hearing aid user

Unable or unwilling to complete complex listening tasks

I have hearing loss in one ear.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are fitted with hearing aids and tested with three different program settings

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any immediate feedback or issues post-treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Phonak Audeo Infinio Hearing Aid

Trial Overview The study is testing the effectiveness of three noise programs in the Phonak Audeo Infinio Hearing Aid on how well participants understand speech. Each participant will try all three settings in a random order without knowing which one they're using at any time.

How Is the Trial Designed?

Group I: Phonak Audeo RIC Experimental Treatment 1 Intervention

All participants are fit with the Audeo RIC hearing aids, which are programmed with three different settings. All participants are tested with all three settings.

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11766019/

Efficacy of Hearing Aids in Patients with Hearing Difficulties in ... FraMatrix and quality of life improved significantly (p < 0.001) with HAs, especially in those with HHL (2.0 dB SNR of speech recognition ...

2. phonak.com phonak.com/content/dam/phonak/en/evidence-library/field-studies/PH_FieldStudyNews_Aud%C3%A9oLife_210x280_EN.pdf

Phonak Field Study News. The primary objective of this study was to confirm that for adults with mild to severe hearing loss, Phonak Audéo Life functioned as expected in terms of ...

3. phonak.com phonak.com/content/dam/phonak/en/evidence-library/field-studies/PH_FieldStudyNews_SCCRealWorld.pdf

Phonak Field Study News. Speech tests appear to be particularly prone to overestimating real-world outcomes, often showing better outcomes at rather low (negative) signal-to-noise (SNR).

4. phonak.com phonak.com/content/dam/phonak/en/evidence-library/white-paper/technical-paper/PH_Insight_TargetTrackMildtoModInfinio_210x297_EN_V1.00.pdf

Phonak Target Track. Data analytics have also proven valuable in audiology, providing insights on adherence to clinical guidelines, types of hearing loss managed with hearing aids, ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06957730

A Comparison of Hearing Aid Noise Programs on Speech ... All participants are fit with the Audeo RIC hearing aids, which are programmed with three different settings. All participants are tested with all three ...

6. phonak.com phonak.com/en-us/support/datasheets

Product Datasheets Find the hearing aid datasheets for Phonak product support.

7. phonakpro.com phonakpro.com/il/en/products/other-products/sds/overview-sds.html

SDS 4.0 Overview SDS 4.0 has a RIC and a BTE Fit and Go Kit. Filled with all the SDS 4.0 components you need to fit Phonak Marvel RIC or BTE hearing aids.

8. phonak.com phonak.com/content/dam/celum/phonak/master-assets/en/documents/hearing-instruments/infinio/user-guides/ph-user-guide-audeo-i-r-92x125-029-1357-02-en.pdf

Phonak Audéo™ I The hearing aids and the compatible charger have the expected service life of five years. The devices are expected to remain safe for use for this duration.

9. davidsonhearingaids.com davidsonhearingaids.com/product/phonak-ric-receivers-4-0/

Phonak RIC SDS 4.0 Receivers These are the original receivers used on the Phonak Audéo Marvel (M), Audéo Paradise (P) and Audéo Lumity (L) models of hearing aids with the CeruShield wax ...

10. phonak.com phonak.com/content/dam/celum/phonak/master-assets/en/documents/hearing-instruments/paradise/audeo-p/ph-user-guide-audeo-p-r-rt-92x125-029-0844-02-029-0844-en.pdf

User Guide: Audéo P-R/RT The Power Pack contains a built-in and non- removable rechargeable lithium-polymer battery. Please also read safety information regarding handling rechargeable ...