Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000028606
Ethics application status
Approved
Date submitted
30/12/2022
Date registered
12/01/2023
Date last updated
15/05/2024
Date data sharing statement initially provided
12/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing remote and in-clinic hearing aid fittings
Scientific title
Remote or in-clinic: the effect of service delivery mode on hearing aid output: study protocol for a double-blinded, randomized trial in adults with mild to moderate sensorineural hearing loss.
Secondary ID [1] 308684 0
Nil known
Universal Trial Number (UTN)
U1111-1286-5895
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hearing loss 328608 0
Condition category
Condition code
Ear 325618 325618 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will have 2 hearing aid fitting interventions (repeated measures, double-blind crossover design): one following standard 'in-clinic' protocols including Real Ear Measurements (on-ear output verification) and one following remote/teleaudiology protocols. For each intervention, participants will wear the hearing aids for 4 weeks with opportunity for subjective sound adjustments. There will be a 2 week 'wash out' period between interventions. At the end of each intervention, final hearing aid output will be measured using Real Ear Measurements.

Total study duration is 12 weeks, including periods between interventions.
Protocol adherence will be monitored at the follow-up appointments through hearing aid data-logging.

In-clinic fitting protocol (duration 60 mins):
For the initial in-clinic hearing aid fitting, participants will be fit binaurally with premium-level, rechargeable, receiver-in-the-canal hearing aids. The receiver and dome configuration will be chosen using standard clinical procedures and be consistent for each participant for the duration of the study. The hearing aids will be programmed through the manufacturer’s software to 100% acclimatisation using the National Acoustics Laboratory Non-Linear 2 (NAL-NL2) prescription targets for long-term hearing aid wearers.
REAR will be verified using a Natus Aurical Freefit and Otometrics Otosuite PMM module, with the gain settings adjusted through hearing aid software to meet NAL-NL2 targets for soft (55dB), medium (65dB) and loud (75dB) stimuli using the International Speech Test Signal. On-ear measurement of maximum power output will be measured at 85dB to ensure estimated uncomfortable loudness levels are not exceeded.
Where hearing aid programming features are available for an in-clinic session but are not available for a remote session, these will be removed from the in-clinic fitting protocol to maintain blinding for the clinicians performing the follow-up appointments.
Hearing aid settings will be optimised using subjective participant feedback to balance overall volume, perceived sound quality, and perception of own voice/occlusion. This process will follow an interview-style approach, with the participant asked to comment on each component and the audiologist making small adjustments to the hearing aid settings until the participant is satisfied with the sound. The hearing aid setting will then be stored and the hearing aids retained at the clinic.

Remote/teleaudiology fitting protocol (duration 60 mins)
Approximately two weeks after the in-clinic hearing aid fitting, a remote hearing aid fitting appointment will take place. The time interval is to allow participants’ memory of the sound of the in-clinic programming to decay so that it is less likely to influence the remote fitting. The same hearing aids used at the in-clinic hearing aid fitting will be reset in-clinic and programmed through hearing aid software to 100% acclimatisation using NAL-NL2 prescription targets for long-term hearing aid wearers. The hearing aids will be programmed to allow for a remote hearing aid connection.
The hearing aids will be sent to the participant via courier.
At the scheduled hearing aid fitting appointment time, the audiologist will telephone the participant to confirm the app installation and Bluetooth pairing was successful. The participant and audiologist will then connect through the app for a remote support session.
Remote support allows an audio-video link between the participant and audiologist. The audiologist will connect to the participant’s hearing aids through a Bluetooth connection with the participant’s smartphone or tablet.
When both the participant and the audiologists are connected to the remote support appointment, the audiologist will perform proxy verification measurements through the hearing aid manufacturer software.
Hearing aid settings will be optimised using subjective participant feedback to balance overall volume, perceived sound quality, and perception of own voice/occlusion. This process will follow an interview-style approach, with the participant asked to comment on each component and the audiologist making small adjustments to the hearing aid settings until the participant is happy with the sound.
The hearing aid settings will be saved, and the participant will return the hearing aids to the clinic through return-post courier.

First and Second Intervention Protocol (duration 30mins each)
The hearing aids will be programmed with the pre-saved settings that relate to each participant’s group allocation. Two weeks after the final fitting appointment, the participants will be sent the hearing aids via courier. They will be instructed to wear them for at least 8 hours per day for two weeks.
At the end of these two weeks, all participants will have a follow-up appointment via remote support with an audiologist who is blinded to the groups. At this appointment, the participants will have the opportunity to have the hearing aids settings adjusted by the audiologist in order to optimise the sound for their personal preferences. This process will follow an interview-style approach, with the participant asked to comment on overall volume, overall sound quality, performance in quiet, performance in noise, and perception of own voice. The audiologist will make small adjustments to the hearing aid settings until the participant is satisfied with the sound.
Participants will be instructed to wear the hearing aids for a further two weeks, and then return to the clinic for the first outcome assessment. The hearing aids will be returned to the clinic at this time.
The second intervention will follow the same process as the first, with the hearing aids programmed with the alternate settings.
Intervention code [1] 325150 0
Rehabilitation
Intervention code [2] 325183 0
Treatment: Devices
Comparator / control treatment
The study design is a randomised crossover study and therefore each participant acts as their own comparator/control
Control group
Active

Outcomes
Primary outcome [1] 333463 0
Hearing aid output assessed by the four-frequency average real-ear aided response (4FREAR)
Timepoint [1] 333463 0
4 weeks after each fitting intervention
Secondary outcome [1] 417175 0
Hearing Handicap Inventory questionnaire
Timepoint [1] 417175 0
Measured 4 weeks after each fitting intervention
Secondary outcome [2] 417176 0
Speech Intelligibility Index score
Timepoint [2] 417176 0
Measured 4 weeks after each fitting intervention
Secondary outcome [3] 417178 0
Abbreviated Profile of Hearing Aid Benefit questionnaire
Timepoint [3] 417178 0
Measured 4 weeks after each fitting intervention
Secondary outcome [4] 417179 0
Sound quality (Likert scale)
Timepoint [4] 417179 0
Measured 4 weeks after each fitting intervention
Secondary outcome [5] 417180 0
Net Promoter Score (NPS): how likely are you to recommend this intervention to others?
Timepoint [5] 417180 0
Measured 4 weeks after each fitting intervention
Secondary outcome [6] 417182 0
Quick Speech-In-Noise measurement
Timepoint [6] 417182 0
Measured 4 weeks after each fitting intervention
Secondary outcome [7] 417324 0
Sound preference: which hearing aid sound did you prefer?
Timepoint [7] 417324 0
Measured 4 weeks after the final intervention

Eligibility
Key inclusion criteria
1. Diagnosed sensorineural hearing loss between mild and moderate, according to WHO definitions, with thresholds unchanged within ±10dB over the past twelve months. Participants with complex hearing needs (tinnitus, single-sided deafness, conductive loss greater than 15dB) are excluded from this study;
2. At least one years’ experience as a hearing aid wearer.
3. Access to a compatible smartphone or tablet with connection to the internet in a suitably private location (min 5Mbs upload/download speed).
4. Available for the duration of the study and to attend in-clinic appointments.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants must have a diagnosed mild to moderate sensorineural hearing loss

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Centralised randomisation on computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Counter-balanced ABAB, stratified according to hearing level (slight, mild, moderate) according to WHO classifications.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sixty participants (thirty per group) will be recruited for the trial. This will provide 90% power at the 5% significance level to detect an overall clinically meaningful difference of 5dB 4FREAR and allow for up to 10% attrition.
The primary outcome measure is the absolute difference between average REAR measures. Secondary measures will be modelled as a 4-way repeated measures general linear model with ear, frequency, signal input level, and fitting method (in-clinic or remote).
All statistical tests will be two-sided at the 5% significance level. All treatment evaluations will be performed on the principle of intention-to-treat (ITT), using the observed data collected from all randomised participants.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2023
Actual
1/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
8
Final
Recruitment outside Australia
Country [1] 25195 0
New Zealand
State/province [1] 25195 0

Funding & Sponsors
Funding source category [1] 312914 0
University
Name [1] 312914 0
University of Auckland
Country [1] 312914 0
New Zealand
Funding source category [2] 312915 0
Commercial sector/Industry
Name [2] 312915 0
GN Resound
Country [2] 312915 0
New Zealand
Primary sponsor type
Individual
Name
Craig Lett
Address
The University of Auckland
School of Population Health
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 314592 0
Individual
Name [1] 314592 0
David Welch
Address [1] 314592 0
The University of Auckland
School of Population Health
Private Bag 92019
Auckland 1142
New Zealand
Country [1] 314592 0
New Zealand
Secondary sponsor category [2] 314630 0
Individual
Name [2] 314630 0
Rosie Dobson
Address [2] 314630 0
School of Population Health
Faculty of Medical and Health Sciences
University of Auckland Private Bag 92019 Auckland Mail Centre 1142 New Zealand
Country [2] 314630 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312187 0
NZ Health and Disabilities Ethics Committee
Ethics committee address [1] 312187 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 312187 0
New Zealand
Date submitted for ethics approval [1] 312187 0
16/01/2023
Approval date [1] 312187 0
12/05/2023
Ethics approval number [1] 312187 0
2023 EXP 14058

Summary
Brief summary
Teleaudiology can potentially improve access to hearing healthcare services. Remote hearing aid fittings offer a new mode of service delivery that removes barriers of geography and access to an audiologist. Real Ear Measurements (REMs) are the gold-standard for hearing aid output verification but require in-clinic appointments. This study will investigate whether remote hearing aid fittings can provide clinically equivalent patient outcomes when compared to current, in-clinic, best-practice guidelines.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123782 0
Mr Craig Lett
Address 123782 0
The University of Auckland
School of Population Health
Private Bag 92019
Auckland 1142
New Zealand
Country 123782 0
New Zealand
Phone 123782 0
+64 0275382062
Fax 123782 0
Email 123782 0
craig.lett@auckland.ac.nz
Contact person for public queries
Name 123783 0
Mr Craig Lett
Address 123783 0
The University of Auckland
School of Population Health
Private Bag 92019
Auckland 1142
New Zealand
Country 123783 0
New Zealand
Phone 123783 0
+64 0275382062
Fax 123783 0
Email 123783 0
craig.lett@auckland.ac.nz
Contact person for scientific queries
Name 123784 0
Mr Craig Lett
Address 123784 0
The University of Auckland
School of Population Health
Private Bag 92019
Auckland 1142
New Zealand
Country 123784 0
New Zealand
Phone 123784 0
+64 0275382062
Fax 123784 0
Email 123784 0
craig.lett@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17953Study protocol  craig.lett@auckland.ac.nz
17954Informed consent form  craig.lett@auckland.ac.nz


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.