Mild to Moderate Sensorineural Hearing LossSelfFitNCT01877317
Study of SelfFit Mobile Medical App for Hearing Loss Diagnostics and Hearing Device Fitting / Fine Tuning
A study testing SelfFit adjusted hearing device in people with Mild to Moderate Sensorineural Hearing Loss, run by Two Pi Signalprocessing Applications GmbH at 1 site in Netherlands.
Trial summary
The purpose of this clinical study is to validate the comparability of prescription formula fitting of hearing aids based on full diagnostic audiometry and SelfFit interactive fitting of hearing aids based on hearing loss screening (mild to moderate hearing losses) using in-situ audiometry, provided and executed… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild to Moderate Sensorineural Hearing Loss
- What is being tested?
- SelfFit adjusted hearing device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2013to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hearing loss at the better ear between 35dB and 50dB (PTA1/2/4)
- Active lifestyle
- No language problems
- No medical contra-indications
- Age: between 18 and 75 years
- About 50% experienced users and 50% new users
- Willing to participate in the trial with one three hour visit to the AMC.
Who cannot join
- Conductive hearing loss in the middle ear
- Severe hearing loss
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Department of Clinical & Experimental Audiology of the Academic Medical Centre
Amsterdam, 1105 AZ
About this study
Official title: Study of SelfFit App for Hearing Loss Diagnostics Based on Threshold Measurements Through In-situ Audiometry and Adjustment of Hearing Device Amplification Parameters in Agreement With Prescriptive Formulas as NAL-NL1,DSL-i/o
The purpose of this clinical study is to validate the comparability of prescription formula fitting of hearing aids based on full diagnostic audiometry and SelfFit interactive fitting of hearing aids based on hearing loss screening (mild to moderate hearing losses) using in-situ audiometry, provided and executed through the mobile medical app.
Read the detailed description
The technology utilized within the mobile medical App is partially described in the US patent application US2011/0002490A1. The app is to be used in combination with a hearing aid to deliver the output and targets accurate individual acoustical amplification for effective compensation of a users hearing loss.
The electronic circuitry incorporating the digital signal processing algorithms - dynamic range compression, noise reduction - is providing the acoustical amplification according to parameters (acoustical gain, compression ratio, time constants) calculated through the App on base of in-situ hearing loss diagnostics (pure tone audiometry, loudness scaling). Within the study, amplification parameters will be transmitted to the prototyped device through a prototyped audio streaming box.
Individual audiogram represents hearing thresholds (softest audible sounds) at different frequencies. At least two test frequencies are used involving one in the lower region of device's bandwidth (such as 750 Hz) and one in the higher region of the device's bandwidth (such as 2 kHz). Hearing thresholds are assessed by presenting pure tones of different known levels (SPL) to the user and the thresholds for each of the test frequencies are determined according to the user response to a verbally formulated question (how many tones did you hear?) and multiple choice answer buttons (0, 1, or 2).
Second hearing loss characteristic obtained by the app. is the personal loudness scaling. By presenting a band-limited noise stimuli and collecting the user response about perceived loudness level Medical Mobile App calculates dynamic range of users hearing at given frequency.
The calculation of optimal amplification parameters is performed by App using a proprietary "fitting formula" derived from scientific data.
Final adjustment of amplification parameters called fine tuning is performed while presenting the user with realistic acoustical environment during operation of the hearing device. Fine tuning relates to slight changes of the parameters initially obtained by the "fitting formula". The acoustical signals are presented using audio streaming through the hearing aid. In particular the presented signals include "speech in quiet" and "speech in background noise". Presented speech signal is composed from two or more sources that are processed with different signal processing parameters. During the presentation of the speech signal App presents the speech source visually as two or more speakers. The user is asked to provide his listening preference by choosing the preferred speaker. The signal processing parameters relating to the preferred sound are used for final adjustment of hearing device.
- Being tested
- SelfFit adjusted hearing device
- Keywords
- Audiology, hearing loss, hearing healthcare, mobile app, hearing aid fitting, audiometry, audiogram
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelfFit adjusted hearing deviceDevice
Also called User-fitted hearing device, hearing device fitting software, home-fitting tool for hearing devices
Comparison of threshold measurements through in-situ audiometry with full diagnostic audiometry; Comparison of First-Fit based on SelfFit-formula with conventional fitting formula NAL-NL1 (IG-measurements; Speech intelligibility with First fit of SelfFit; Speech intelligibility with Final fit of SelfFit; Comparison of fine tuning through SelfFit (Final fit) with First fit; Comparison of Final fit with Traditional fit (conventional fitted hearing aid of the test person)
| Study group | Role | What they receive |
|---|---|---|
| SelfFit adjusted hearing device | Experimental | Hearing impaired people with mild to moderate sensorineural hearing loss (PTA124<50 dB) in the test ear compare the performance of their hearing aids adjusted through SelfFit mobile medical App (I-Pad) with the performance of their hearing aids adjusted through conventional audiogram-based fitting. Receives: Device: SelfFit adjusted hearing device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing threshold
Applicability of in-situ audiometry:
Comparison of pure tone audiometry outcomes: conventional full diagnositic and SelfFit in-situ audiometry
Measured: June - July 2013 (up to 2 months)
Secondary outcomes (1)
Speech intelligibility - First Fit
Quality of First-Fit:
Comparison speech audiometry with CVC words @ 55/65/75 db SPL in conventionally adjusted hearing aid and SelfFit adjusted hearing aid
Measured: June - July 2013 (up to 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate Sensorineural 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Two Pi Signalprocessing Applications GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wouter A Dreschler, Prof.dr.ir., Principal investigator, Department of Clinical & Experimental Audiology of the Academic Medical Centre in Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877317
- Sponsor's protocol ID
- ZIT-653820
- Other IDs
- NL44209.018.13
- Acronym
- SelfFit
- Status last verified
- Oct 2016
- First submitted
- 28 May 2013
- Last updated
- 24 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of SelfFit App for Hearing Loss Diagnostics Based on Threshold Measurements Through In-situ Audiometry and Adjustment of Hearing Device Amplification Parameters in Agreement With Prescriptive Formulas as NAL-NL1,DSL-i/o
- ClinicalTrials.gov ID
- NCT01877317
- Acronym / sponsor ID
- SelfFit / ZIT-653820
- Keywords
- Audiology, hearing loss, hearing healthcare, mobile app, hearing aid fitting, audiometry, audiogram
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Two Pi Signalprocessing Applications GmbHIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 13 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical study is to validate the comparability of prescription formula fitting of hearing aids based on full diagnostic audiometry and SelfFit interactive fitting of hearing aids based on hearing loss screening (mild to moderate hearing losses) using in-situ audiometry, provided and executed through the mobile medical app.
Detailed description
The technology utilized within the mobile medical App is partially described in the US patent application US2011/0002490A1. The app is to be used in combination with a hearing aid to deliver the output and targets accurate individual acoustical amplification for effective compensation of a users hearing loss.
The electronic circuitry incorporating the digital signal processing algorithms - dynamic range compression, noise reduction - is providing the acoustical amplification according to parameters (acoustical gain, compression ratio, time constants) calculated through the App on base of in-situ hearing loss diagnostics (pure tone audiometry, loudness scaling). Within the study, amplification parameters will be transmitted to the prototyped device through a prototyped audio streaming box.
Individual audiogram represents hearing thresholds (softest audible sounds) at different frequencies. At least two test frequencies are used involving one in the lower region of device's bandwidth (such as 750 Hz) and one in the higher region of the device's bandwidth (such as 2 kHz). Hearing thresholds are assessed by presenting pure tones of different known levels (SPL) to the user and the thresholds for each of the test frequencies are determined according to the user response to a verbally formulated question (how many tones did you hear?) and multiple choice answer buttons (0, 1, or 2).
Second hearing loss characteristic obtained by the app. is the personal loudness scaling. By presenting a band-limited noise stimuli and collecting the user response about perceived loudness level Medical Mobile App calculates dynamic range of users hearing at given frequency.
The calculation of optimal amplification parameters is performed by App using a proprietary "fitting formula" derived from scientific data.
Final adjustment of amplification parameters called fine tuning is performed while presenting the user with realistic acoustical environment during operation of the hearing device. Fine tuning relates to slight changes of the parameters initially obtained by the "fitting formula". The acoustical signals are presented using audio streaming through the hearing aid. In particular the presented signals include "speech in quiet" and "speech in background noise". Presented speech signal is composed from two or more sources that are processed with different signal processing parameters. During the presentation of the speech signal App presents the speech source visually as two or more speakers. The user is asked to provide his listening preference by choosing the preferred speaker. The signal processing parameters relating to the preferred sound are used for final adjustment of hearing device.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SelfFit adjusted hearing device | Experimental | Device: SelfFit adjusted hearing deviceHearing impaired people with mild to moderate sensorineural hearing loss (PTA124<50 dB) in the test ear compare the performance of their hearing aids adjusted through SelfFit mobile medical App (I-Pad) with the performance of their hearing aids adjusted through conventional audiogram-based fitting. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Hearing loss at the better ear between 35dB and 50dB (PTA1/2/4)
- Active lifestyle
- No language problems
- No medical contra-indications
- Age: between 18 and 75 years
Key exclusion criteria (2 listed)
- Conductive hearing loss in the middle ear
- Severe hearing loss
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 |
|---|---|---|
| SelfFit adjusted hearing deviceAlso: User-fitted hearing device, hearing device fitting software, home-fitting tool for hearing devicesComparison of threshold measurements through in-situ audiometry with full diagnostic audiometry; Comparison of First-Fit based on SelfFit-formula with conventional fitting formula NAL-NL1 (IG-measurements; Speech intelligibility with First fit of SelfFit; Speech intelligibility with Final fit of SelfFit; Comparison of fine tuning through SelfFit (Final fit) with First fit; Comparison of Final fit with Traditional fit (conventional fitted hearing aid of the test person) | Device | SelfFit adjusted hearing device |
Primary outcome
Hearing threshold
Time frame: June - July 2013 (up to 2 months)
Applicability of in-situ audiometry: Comparison of pure tone audiometry outcomes: conventional full diagnositic and SelfFit in-situ audiometry
1 secondary outcome
Speech intelligibility - First Fit
Time frame: June - July 2013 (up to 2 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
- Individual participant dataSharing planned: No
Related trials for Mild to Moderate Sensorineural Hearing Loss
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Clinical Evaluation of the RH210 Hearing Aid
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Hearing Loss
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.
Wouter A Dreschler, Prof.dr.ir. principal investigator
Department of Clinical & Experimental Audiology of the Academic Medical Centre in Amsterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SelfFit adjusted hearing device in people with Mild to Moderate Sensorineural Hearing Loss, run by Two Pi Signalprocessing Applications GmbH at 1 site in Netherlands.
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 7 inclusion and 2 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 24 Oct 2016. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hearing threshold (time frame: June - July 2013 (up to 2 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Oct 2016.