Tokyo, Oct. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063054) titled 'A prospective interventional study on the feasibility of remote hearing care and hearing aid guidance using hearing aid specialty stores as remote sites' on Oct. 25.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Kyoto University Hospital

Condition: Condition - Hearing loss (patients using, trialing, or considering hearing aids) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the feasibility of a remote hearing care and hearing aid guidance system in which otolaryngologists/certified hearing aid consultant physicians at Kyoto University Hospital use Webex to review hearing aid use, provide fitting guidance, and determine the need for hospital visits, with certified hearing aid technicians and, when needed, speech-language-hearing therapists present at hearing aid specialty stores serving as remote sites. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Remote hearing aid care and guidance via Webex (approximately 1 to 3 sessions per participant, 30 to 60 minutes per session, up to about twice a month). A certified hearing aid technician is present at the remote site (e.g., Ishitsubo Co., Ltd. Fukuchiyama store), with a speech-language-hearing therapist present as needed. Otolaryngologists/certified hearing aid consultant physicians at Kyoto University Hospital perform the following: (1) Problem identification: assessment of problems with hearing aid use based on the participant's hearing complaints, hearing aid model, settings and fitting history, data logging (daily use time), and audiometric results. (2) Advice and guidance on hearing aid use: advice to the participant on how, how long, and in what situations to use hearing aids, and guidance to the certified hearing aid technician on fitting adjustments. (3) Determination of the need for an otolaryngology visit: when physical examination, further testing, or treatment is judged necessary, an in-person visit to Kyoto University Hospital or a nearby medical institution is recommended. Sessions are audio/video recorded and transcribed as needed. Physical examination, prescriptions, procedures, and preparation of medical documents are not performed during remote sessions.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Aged 18 years or older 2) Patients with hearing loss who are using, trialing, or considering hearing aids 3) Able to receive remote hearing aid care/guidance via Webex at a remote site such as Ishitsubo Co., Ltd. Fukuchiyama store or Fukuchiyama City Hearing and Speech Disability Center 4) Able to understand the study and provide written informed consent, including consent to audio/video recording and transcription Key exclusion criteria - 1) Patients with acute symptoms such as sudden hearing loss, otalgia, otorrhea, or vertigo, or suspected acute disease 2) Patients judged by a physician to require immediate physical examination (e.g., tympanic membrane or ear canal findings) 3) Patients who do not consent to Webex connection, the presence of accompanying staff at the remote site, or audio/video recording and transcription 4) Others judged inappropriate by the principal investigator or attending physician Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 09 Month 24 Day Anticipated trial start date - 2026 Year 12 Month 01 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072174

Disclaimer: Curated by HT Syndication.