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Teleaudiology hearing aid fitting follow-up consultations for adults

Teleaudiology hearing aid fitting follow-up consultations for adults: an evaluation of a translational study through a single-blinded randomized controlled trial and mini-cohort

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000286145
Enrollment
56
Registered
2019-02-25
Start date
2016-09-13
Completion date
2017-11-03
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Participants were ordinary patients of real world clinics. Participants in both groups received two follow-up hearing aid fitting consultations (face-to-face and remote respectively delivered at the clinic and at participant's home/office), and a third consultation at their homes for outcome assessment where interventions were applied to address their individual needs. A combination of measures were used to assess changes in participants' communication, fitting, aspects of quality of life, service and hearing aid aspects, outcomes that are already part of routine clinical procedures. Objective: To compare outcomes of the follow-up consultations for hearing aid fittings conducted remotely by telehealth to those conducted face-to-face by conventional consultations, utilizing subjective measures. The overall hypothesis of this study is that participants’ outcomes with remote consultation will not significantly differ from those with face-to-face consultation.

Interventions

Description of interventions below are following the TIDieR checklist as recommended. 1. Brief name: Standard face-to-face and teleaudiology (remote) hearing aid fitting follow-up consultations were delivered for adults (new and experienced hearing aid users) 2. Why: Hearing loss is the fourth leading cause of years lived with disability. There is currently over 466 million people with disabling hearing loss across the globe. This number is expected to double by 2050. One of the main barriers to

Description of interventions below are following the TIDieR checklist as recommended. 1. Brief name: Standard face-to-face and teleaudiology (remote) hearing aid fitting follow-up consultations were delivered for adults (new and experienced hearing aid users) 2. Why: Hearing loss is the fourth leading cause of years lived with disability. There is currently over 466 million people with disabling hearing loss across the globe. This number is expected to double by 2050. One of the main barriers to deliver timely services to these people is related to the imbalance between supply and demand in terms of number of patients versus hearing professionals, and their disproportional geographical distribution. The physical as well as economic barriers make difficult for patients to reach a clinic. Consultations at a distance (teleaudiology) would help to improve access to hearing services and reduce the global burden of unaddressed hearing loss. Rehabilitation with hearing aids fitting is the primary intervention for disabling hearing loss. Follow-up hearing aid fitting consultations are the most demading and necessary type of appointment after hearing aid fitting due to the complexity of adjusting the hearing aids to the patients' individual needs and ensure the delivery of the optimum benefit, satisfaction and handicap reduction for patients, which can reflect on their quality of life. 3. Materials: Two laptop computers with Microsoft Windows 10 operating system and two ‘dongles’ to provide 4G mobile internet connectivity were used for remote consultations. Both laptops had the same configurations and replicated the standard audiology computer system including software packages: (a) Noah (HIMSA, Copenhagen, Denmark) with Phonak and Unitron fitting software (Sonova Group, Stäfa, Switzerland) to programme hearing aids, and (b) TeamViewer Business (Goppingen, Germany) to enable the facilitator’s laptop to be controlled by the audiologist’s laptop and video-conferencing between the two sites. A portable bluetooth speaker on the remote site was used to provide better sound than the laptop speaker, and the audiologist used a headset. The laptops microphones used. The facilitator assisting the audiologist and patient on the remote site was also equipped with hearing aid accessories (e.g. otoscope, domes, cerustops, magnets, rotary tool for drilling and griding, cleaning kit, receivers, slim tubes, etc.), and paper copies of the study surveys that needed to be applied straight after the consultation. 4. Procedures: Participants received the fitting of hearing aids in the clinic as standard routine practice. Their care was continued as part of this study by another audiologist. The consistency of the clinical procedures were maintained in both teleaudiology and conventional follow-up consultations in which interventions were focused on the needs of each patient (patient-centred service). After greeting the patient, the audiologist (i) enquired whether there was any improvement in communication difficulties reported prior HA fitting, (ii) identified and/or assessed fitting issues or needs related to physical comfort, sound parameters or ease of management, (iii) addressed the (new) issues (if any) that patient could have been experiencing (e.g. “echoey” speech sound) and/or the audiologist could have identified (e.g. difficulty in correctly positioning the ear piece in the ear canal) through fine-tuning, counselling (including communication strategies) and instructions (including demonstrations and testing, e.g. phone use), (iv) addressed any further questions or doubts the participant and/or his/her significant other person had, (v) informed the patient on what the next step was and what he/she or the audiologist would expect for the next period until the next appointment, and (vi) made sure that all was clear for the patient, that they were happy with apparent result, and then finalized the consultation. 5. Who provided: All the follow-up consultations were provided by the same certified and licensed audiologist with 15 years of clinical experience to control for clinican's expertise. The remote consultations were delivered with the assistance of a facilitator who acted as the audiologist's hands on the remote side to help the audiologist and the patient. To control for the level of experience in assisting the audiologist and patient during the remote consultations, four volunteers in the first year of a Masters in Audiology course, who had basic HAs knowledge but as yet no practical experience acted as the facilitators. Prior to the start of the study, they received face-to-face training on the technical and clinical tasks that they would be required to undertake. 6. How, and 7. where: Two groups with participants randomized for their experience with hearing aids were recruited. Participants in each group received one standard face-to-face and one teleaudiology follow-up consultation in opposite order for first and second consultation. Group 1 (G1) received their first follow-up consultation face-to-face and their second consultation remotely. Group 2 (G2) received their follow-up consultations in the other order, first remotely and secondly face-to-face. Face-to-face consultations were delivered at the clinic as per conventional practice and remote consultations were delivered at the participants' most convenient places (e.g. home, office, clinic) through synchronous (real time video-conference) teleaudiology. The audiologist remotely controlled the fitting software installed in the remote computer and the hearing aids were wiressly programmed through the use of a wireless programming interface (iCube II or Noahlink). During remote consultations, if on occasions the internet connection or transmission of data was poor such that it compromised the communication, a telephone call using the speaker-phone facility was used. Each participant was seen three times by the research audiologist: two follow-up consultations and a third consultation for assessment of outcomes. Service was provided for participants who needed further intervention at this final consultation after the end of the study. 8. When and how much: The study was controlled for the number of interventions. Two follow-up consultations were delivered for each participant and participants did not receive any extra consutlations or any other clinical assistance between consultations, at the clinic in-person or by phone or email, during the study. In addition, the intervals between consultations were controlled through coordination of the availability of participants, facilitators and audiologist, as well as re-bookings resulting from unexpected issues (e.g. sickness), to ensure that intervals were in most cases between 7 to 14 days and thereby, reflecting as closely as possible standard clinical practice for the timing of follow-up consultations. The duration of the consultations was registered and was supposed to be delivered within approximately 45 minutes as per normal clinic routine. 9. and 10. Tailoring and modifications: This study presents a methodology that was incorporated into routine clinical practice of three audiology clinics (Lions Hearing Clinics) in southern, eastern and northern urbans area of Perth, Western Australia. There was minimal disruption to routine clinical practice in relation to the bookings and occasional re-bookings of appointments for the study. Consultations only differed from each other on the mode of delivery. All the clinical procedures (physical and sensory management, instructions and counselling) involved in the HA fitting and follow-up consultations were delivered as they are normally in conventional clinical routine.Ear impressions and real ear measurements (REMs) were not performed in the follow-up consultations due to the need of expensive equipment to be on the remote side and because it is rarely used in follow-up hearing aid fitting consultations. Hearing aid adjustments were based on the REM traces resulted from the fitting consultation and on the fitting needs reported by the participants or identified by the audiologist. Clinical best practices were required to be followed in the clinics from where the participants were recruited and these continued in the care provided as part of this study, as described in the procedures above. 11. and 12. The outcome assessor was the audiologist as it usually is in routine practice. The audiologist who delivered the follow-up consultations made use of a checklist regarding the application of the tools for each participant’s face-to-face and remote consultations for consistency of clinical and research procedures.

Sponsors

Ear Science Institute Australia
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

The inclusion and exclusion criteria for participation were designed to include people who are typically seen in hearing aid clinics. Inclusion criteria: (i) new HA users who were to be fitted with HAs for the first time, (ii) experienced HA users (with at least 1 year of HA use) to be fitted with a different set of aids compared to those previously worn, (iii) were over 18 years of age, (iv) could speak fluent English, and (v) were in good general health. All types, severities and configurations of hearing loss were accepted.

Exclusion criteria

Those who were in a dependent relationship that precluded them from making independent decision, or unable to perform tasks required due to an underlying physical or mental condition (e.g. difficulty to recall information, unable to provide answers to questions, move arms and hands, presented with visual severe impairment, etc.) were not included.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026