ClinicalTrials.gg
Not yet recruitingNCT06746038Updated Dec 24, 2024

Evaluation of Extended Wear Hearing Aid for Mild Hearing Loss

An interventional study of Extended Wear Hearing Aid in Sensorineural Hearing Loss, sponsored by Sonova AG. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-24.

Sponsored by Sonova AG · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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. Participants will be experienced hearing aid users who have previously worn or currently wear extended wear hearing devices. The primary objective will be to assess subjective listening effort, compared to unaided.

02

Conditions studied

  • Sensorineural Hearing Loss

Keywords

  • extended wear hearing aid
03

In context

Hearing Loss, Sensorineural

346 studies on the registry are indexed under Hearing Loss, Sensorineural; 100 are open to participants now.

This study's planned enrollment of 10 is below the median of 32 across 247 interventional studies indexed under Hearing Loss, Sensorineural.

Browse Hearing Loss, Sensorineural studies →

Lead sponsor

Sonova AG is the lead sponsor of 89 studies on the registry; 6 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Meets requirements outlined on Lyric Candidacy Form
  • Current Lyric hearing instrument user
  • 18 years of age or older at time of enrollment in the study
  • Mild sensorineural hearing loss as defined by WHO, 4 frequency PTA of 20-34 dB HL, in the better hearing ear
  • Good understanding (read/write/speak) of the English language
  • Willingness to comply with all study requirements

Exclusion criteria

Exclusion Criteria:

  • 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
  • Impairments that would restrict participation in any of the evaluations
  • Ear health conditions present at baseline that prevent immediate device replacement
  • Conditions that would indicate the need for medical referral prior to hearing aid fitting, according to clinic's standard protocol
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Experimental Group

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

    Device: Extended Wear Hearing Aid

Interventions

  • DeviceExtended Wear Hearing Aid

    Extended wear hearing aid means that the device is worn 24 hours per day, 7 days a week for months at a time. However, this study will only fit devices on participants for one testing session lasting 2 hours.

    Also known as: Lyric4

06

What researchers measure

Primary outcomes

  1. NASA Task Load Index (NASA-TLX)

    A raw score on six demensions (mental demand, physical demand, temporal demand, frustration, effort, performance) on a scale from 1 (low/good) to 20 (high/poor). A higher score indicates higher levels of subjective effort.

    Time frame: Day 1 of 1 day study

Secondary outcomes

  1. AZBio Speech in noise testing

    The percentage of words correctly repeated by the participant when listening to sentences played from a front speaker at a certain dB level, while background noise is presented simultaneously from four corner speakers. A higher percentage indicates better speech understanding in noise.

    Time frame: Day 1 of 1 day study

07

Study locations

1 site
  • The Woodlands Hearing Center
    Shenandoah, Texas 77384, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2025; primary completion for Mar 2025, 2 months later.

Of 80 industry-sponsored interventional studies with no phase under Hearing Loss, Sensorineural, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 23. This study's planned 2 months is below that.

Counting every sponsor, half of 162 studies reached it within 22 months; a quarter within 6 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 18, 2024
First posted
Dec 24, 2024
StartEst.
Jan 15, 2025
Primary completionEst.
Mar 15, 2025
CompletionEst.
Mar 15, 2025
Last update
Dec 24, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06746038
Lead sponsor
Sonova AG
Collaborators
The Woodlands Hearing Center
Responsible party
Sponsor
First posted
Dec 24, 2024
Start date
Jan 15, 2025 (estimated)
Primary completion
Mar 15, 2025 (estimated)
Completion
Mar 15, 2025 (estimated)
Last update
Dec 24, 2024

Study contacts

Study Manager
Contact
PARCResearch@phonak.com
630-821-5000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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