Hearing LossNCT06138665

Evaluation of a New Noise Reduction Strategy in Hearing Aids

A study testing Phonak Audeo Infinio Sphere, Hearing aid B and Hearing aid C in people with Hearing Loss, run by Sonova AG at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hearing Loss
What is being tested?: Phonak Audeo Infinio Sphere, Hearing aid B and Hearing aid C
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteUnited States
Study dates: 20 Nov 2023to 31 Mar 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

bilateral and symmetrical severe hearing loss
experienced hearing aid user 6 months+ hearing aid use
good understanding of English language
able and willing to wear RIC style hearing aids with custom earpieces

Who cannot join

unilateral hearing loss
mild hearing loss
inability to follow verbal directions
presence of ear infection, middle ear fluid, dizziness, or worsening of hearing loss within last 90 days

Trial locations and contacts

1 site in 1 country.

United States1 site

Phonak Audiology Research Center
Aurora, Illinois, 60504

Other trials in United States

About this study

The goal of this exploratory interventional study is to evaluate a new hearing aid noise-reduction strategy in experienced hearing aid users, compared to currently available strategies. The primary objective is to measure speech in noise performance with a new strategy and compare to the performance with currently available strategies via a coordinate response measure task.

Conditions: Hearing Loss
Being tested: Phonak Audeo Infinio Sphere, Hearing aid B, Hearing aid C
Medical subject headings: Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Phonak Audeo Infinio SphereDevice
Experimental device
Hearing aid BDevice
Active comparator device from different manufacturer that is currently available
Hearing aid CDevice
Active comparator device from different manufacturer that is currently available

Study groups in NCT06138665
Study group	Role	What they receive
Device A, then Device B, then Device C	Experimental	Participants fit with investigational device (device A), then comparator device B, then comparator device C Receives: Device: Phonak Audeo Infinio Sphere; Device: Hearing aid B; Device: Hearing aid C
Device B, then Device A, then Device C	Experimental	Participants fit with comparator device B first, then investigational device (device A), then comparator device C Receives: Device: Phonak Audeo Infinio Sphere; Device: Hearing aid B; Device: Hearing aid C
Device A, then C, then B	Experimental	Participants fit with investigational device A first, then comparator device C, then comparator device B Receives: Device: Phonak Audeo Infinio Sphere; Device: Hearing aid B; Device: Hearing aid C
Device B, then Device C, then Device A	Experimental	Participants fit with comparator device B first, then comparator device C, then investigational device A Receives: Device: Phonak Audeo Infinio Sphere; Device: Hearing aid B; Device: Hearing aid C
Device C, then B, then A	Experimental	Participants fit with comparator device C first, then comparator device B, then investigational device A Receives: Device: Phonak Audeo Infinio Sphere; Device: Hearing aid B; Device: Hearing aid C
Device C, then A, then B	Experimental	Participants fit with comparator device C first, than investigational device A, then comparator device B Receives: Device: Phonak Audeo Infinio Sphere; Device: Hearing aid B; Device: Hearing aid C

What is being measured

The primary outcome is the main question the study is designed to answer.

Coordinate Response Measure
Test measures speech perception in the presence of 5 competing talkers, presented from 5 speakers located in front of the participant. The talkers are presented sequentially with a brief offset of 1.2 seconds. One of the talkers is the target talker and the participant is instructed to listen for a specific call sign, which identifies the target talker. The participant is prompted to identify the color and number that is subsequently spoken by the target talker. The location of the target talker is randomized from the five locations in the front hemisphere. A score of correctly repeated color and number is calculated and a higher score is better. The dB levels at which the target talker and competing talkers are presented are determined individually for each participant by the Speech in Noise Test, described in Outcome 4.
Measured: 1 day (lab visit 2)

Secondary outcomes (2)

ACALES (Adaptive Categorical Listening Effort Scaling)
An adaptive method of measuring subjective listening effort. Three sentences are presented sequentially in noise. The listener rates their subjective effort on a 13-point scale that goes from Effortless (1) to Extremely Effortful (13). There is a 14th point which is labeled "Only Noise" and indicates no speech was heard. After each rating, the volume of the speech adapts. The algorithm is designed to capture the SNR (Signal to Noise Ratio) that includes both the effortless and the extremely effortful rating for an individual. Listeners rate different SNR levels using the scale, for instance, a listener may rate an SNR of -12 dB (where speech is 12 dB softer than the noise) as Very Effortful, or 11 on the scale, while rating a SNR of -2 (where speech is only 2 dB softer than noise) as Effortless or a 1 on the scale. In comparing HA settings, that which has the least negative SNR for a particular rating on the scale indicates less effort.
Measured: 1 day (lab visit1)
Subjective Rankings of Each Hearing Aid
Participants ranked the three devices on a scale from 1 (worst) to 5 (best) for five characteristics: Noise suppression, overall satisfaction, speech clarity, speech loudness, speech naturalness. For each participant, ranks were assigned to each device based on the rating it received, with 1 being the highest rank and 3 being the lowest rank. The frequency of each rank was then calculated for each device across all raters. Results are displayed in the count of devices in each ranking. No statistical analysis was performed on this measure.
Measured: 1 day (lab visit 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Nov 202331 Mar 2024

First posted18 Nov 2023
Study start20 Nov 2023
Primary completion31 Mar 2024
Study completion31 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hearing LossStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Participants will undergo multiple speech in noise tasks and a listening effort task with a Phonak hearing aid and two comparator hearing aids.
Masking: Single blind
Who is masked: Participant
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06138665
Sponsor's protocol ID: SRF-20473
Status last verified: Dec 2025
First submitted: 14 Nov 2023
Last updated: 19 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: No individual data will be shared with other researchers

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hearing Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of a New Noise Reduction Strategy in Hearing Aids
ClinicalTrials.gov ID: NCT06138665
Acronym / sponsor ID: SRF-20473
Conditions: Hearing Loss
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Sonova AGIndustry (pharma, biotech, devices)
Study start: 20 Nov 2023 (actual)
Primary completion: 31 Mar 2024 (actual)
Study completion: 31 Mar 2024 (actual)
First posted: 18 Nov 2023 (actual)
Results: Posted 19 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 6
Model description: Participants will undergo multiple speech in noise tasks and a listening effort task with a Phonak hearing aid and two comparator hearing aids.

Arm	Type	Receives
Device A, then Device B, then Device C	Experimental	Device: Phonak Audeo Infinio Sphere, Device: Hearing aid B, Device: Hearing aid CParticipants fit with investigational device (device A), then comparator device B, then comparator device C
Device B, then Device A, then Device C	Experimental	Device: Phonak Audeo Infinio Sphere, Device: Hearing aid B, Device: Hearing aid CParticipants fit with comparator device B first, then investigational device (device A), then comparator device C
Device A, then C, then B	Experimental	Device: Phonak Audeo Infinio Sphere, Device: Hearing aid B, Device: Hearing aid CParticipants fit with investigational device A first, then comparator device C, then comparator device B
Device B, then Device C, then Device A	Experimental	Device: Phonak Audeo Infinio Sphere, Device: Hearing aid B, Device: Hearing aid CParticipants fit with comparator device B first, then comparator device C, then investigational device A
Device C, then B, then A	Experimental	Device: Phonak Audeo Infinio Sphere, Device: Hearing aid B, Device: Hearing aid CParticipants fit with comparator device C first, then comparator device B, then investigational device A
Device C, then A, then B	Experimental	Device: Phonak Audeo Infinio Sphere, Device: Hearing aid B, Device: Hearing aid CParticipants fit with comparator device C first, than investigational device A, then comparator device B

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

bilateral and symmetrical severe hearing loss
experienced hearing aid user 6 months+ hearing aid use
good understanding of English language
able and willing to wear RIC style hearing aids with custom earpieces

Key exclusion criteria (4 listed)

unilateral hearing loss
mild hearing loss
inability to follow verbal directions
presence of ear infection, middle ear fluid, dizziness, or worsening of hearing loss within last 90 days

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Phonak Audeo Infinio SphereExperimental device	Device	Device A, then C, then B, Device A, then Device B, then Device C, Device B, then Device A, then Device C, Device B, then Device C, then Device A, Device C, then A, then B, Device C, then B, then A
Hearing aid BActive comparator device from different manufacturer that is currently available	Device	Device A, then C, then B, Device A, then Device B, then Device C, Device B, then Device A, then Device C, Device B, then Device C, then Device A, Device C, then A, then B, Device C, then B, then A
Hearing aid CActive comparator device from different manufacturer that is currently available	Device	Device A, then C, then B, Device A, then Device B, then Device C, Device B, then Device A, then Device C, Device B, then Device C, then Device A, Device C, then A, then B, Device C, then B, then A

Primary outcome

Coordinate Response Measure
Time frame: 1 day (lab visit 2)
Test measures speech perception in the presence of 5 competing talkers, presented from 5 speakers located in front of the participant. The talkers are presented sequentially with a brief offset of 1.2 seconds. One of the talkers is the target talker and the participant is instructed to listen for a specific call sign, which identifies the target talker. The participant is prompted to identify the color and number that is subsequently spoken by the target talker. The location of the target talker is randomized from the five locations in the front hemisphere. A score of correctly repeated color and number is calculated and a higher score is better. The dB levels at which the target talker and competing talkers are presented are determined individually for each participant by the Speech in Noise Test, described in Outcome 4.

2 secondary outcomes

ACALES (Adaptive Categorical Listening Effort Scaling)
Time frame: 1 day (lab visit1)
Subjective Rankings of Each Hearing Aid
Time frame: 1 day (lab visit 1)

Results and safety

Results posted to the registry on 19 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants Who Started With Phonak Device A, Then Device B, Then Device C	3	3
Participants Who Started With Device A, Then C, Then B	3	2
Participants Who Started With Device B, Then A, Than C	2	2
Participants Who Started With Device B, Then C, Then A	3	3
Participants Who Started With Device C, Then A, Then B	3	2
Participants Who Started With Device C, Then B, Then A	3	3

Primary outcome: Coordinate Response Measure

Time frame: 1 day (lab visit 2). Mean (Standard Deviation). Unit: Percent correct responses

Measure	All Participants Who Completed the CRM Task n = 9
Target speech at 60 degrees, condition Phonak HA with New Noise Reduction Feature OFF	81.9 (19)
Target speech at 60 degrees, condition Phonak HA with New Noise Reduction Feature ON	90 (10)
Target speech at 60 degrees, condition Phonak HA with New NR feature ON at proposed settings	87.5 (9)
Target speech at 60 degrees, condition Competitor HA B with current Noise Reduction ON	59.7 (25)
Target speech at 60 degrees, condition Competitor HA C with current Noise Reduction ON	78.1 (25)
Target speech at 120 degrees, condition Phonak HA with New Noise Reduction Feature OFF	56.9 (19)
Target speech at 120 degrees, condition Phonak HA with New Noise Reduction Feature ON	76.4 (20)
Target speech at 120 degrees, Phonak HA with New Noise Reduction Feature ON at proposed settings	58.3 (19)

All Participants Who Completed the CRM Task: Odds Ratio (OR): 1.89 (95% CI 1.27 to 2.8)
All Participants Who Completed the CRM Task: Odds Ratio (OR): 3.44 (95% CI 2.35 to 5.03)
All Participants Who Completed the CRM Task: Odds Ratio (OR): 2.79 (95% CI 1.85 to 4.2)

Population analysed: Out of 17 recruited participants, only 9 were able to complete the task.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participants were observed during the time which they spent in the lab for testing which was one day.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants Who Were Fit With Device A, Then Device B, Then Device C	0 of 3 (0%)	0 of 3 (0%)	0 of 3
All Participants Who Were Fit With Device A, Then Device C, Then Device B	0 of 3 (0%)	0 of 3 (0%)	0 of 3
All Participants Who Were Fit With Device B, Then Device A, Then Device C	0 of 2 (0%)	0 of 2 (0%)	0 of 2
All Participants Who Were Fit With Device B, Then Device C, Then Device A	0 of 3 (0%)	0 of 3 (0%)	0 of 3
All Participants Who Were Fit With Device C, Then Device A, Then Device B	0 of 3 (0%)	0 of 3 (0%)	0 of 3
All Participants Who Were Fit With Device C, Then Device B, Then Device A	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. No individual data will be shared with other researchers

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Phonak Audeo Infinio Sphere, Hearing aid B and Hearing aid C in people with Hearing Loss, run by Sonova AG at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Coordinate Response Measure (time frame: 1 day (lab visit 2)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06138665.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.