臨床研究等提出・公開システム

Japanese

Date of registration	July. 17, 2025
Last modified on	July. 17, 2025
Trial ID	jRCTs032250240

Scientific Title	A study of the function of programmed and conventional hearing aids in patients with mild to moderate hearing loss. (A study of the function of programmed and conventional hearing aids in patients with mild to moderate hearing loss.)
Public Title	Study of programmed hearing aids

Contact for Scientific Queries	Name	Kanzaki Sho
	Affiliation	National Hospital Organization of Tokyo Medical Center
	Address	2-5-1 Higashigaoka Meguro Tokyo
	Telephone	+81-334110111
	E-mail	shokanza@yahoo.co.jp
Contact for Public Queries	Name	Kanzaki Sho
	Affiliation	National Hospital organization of Tokyo Medical Center
	Address	2-5-1 Higashigaoka Meguro Tokyo
	Telephone	+81-334110111
	E-mail	shokanza@yahoo.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		July. 17, 2025
Target sample size		40
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	active control
	assignment	factorial assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients who meet all of the following criteria (1)Patients whose written consent has been obtained by the individual. (2)Patients with sensorineural hearing loss in at least one ear, with an average of at least 25 dB and less than 70 dB at the four frequencies of 500 Hz,1000 Hz, 2000 Hz,and 4000 Hz on pure tone audiometry. (2)Mild to moderate range of hearing loss (between 25 dB and 70 dB) as defined by the quartiles (0.5,1,2,and 4 kHz) of pure tone audiometry. (3)Audiometric testing of speech sounds with best speech intelligibility greater than or equal to 50% in both ears. (4)Females and Male, 18 years of age or older at the time consent is obtained.
	Exclusion Criteria	(1)Patients with perforated eardrum. (2)Patients with congenital hearing loss. (3)Patients with cognitive impairment or psychiatric disorders that may interfere with the examination upon interview. (4)Other patients deemed by the principal/assistant investigator to be excluded due to safety concerns or other reasons.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Hearing loss
Intervention(s)		Hearing aid
Health Condition(s) Keyword		Hearing loss
Intervention(s) Keyword		Hearing aid
Health Condition(s) Code		C09.218.458.341 C10.597.751.418.341 C23.888.592.763.393.341
Intervention(s) Code		E07.305.906.500 E07.814.458
Primary Outcome(s)		Average of hearing level of Sound field hearing test(dB)
Secondary Outcome(s)		Sound field Speech test, speech in noise, real-ear measurement

Source of Monetary Support / Secondary Sponsor	Sivantos Co.

Name of Certified Review Board	Cocoromi Certified Review Board
Address	3-1501-1,A-203,Kosugimachi,Nakahara-ku, Kawasaki, Kanagawa, Kanagawa, Kanagawa
Telephone	+81-42-742-1130
E-Mail	crb-office@cocoromi-crb.co.jp
Approval Status	Approval
Date of approval	April. 28, 2025

Plan to share IPD	No
Plan description	Data is compiled at representative facilities.

Countries of Recruitment（Except Japan）	none