Applicability of the compact peripheral nerve stimulator for non-invasive electrical auditory stimulation (NIEAS)

JRCT ID: jRCTs072190004

Registered date:24/04/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: hearing loss
• Date of first enrollment: 20/04/2020
• Target sample size: 20
• Study type: Interventional
• Intervention(s): none

Outcome(s)

Primary Outcome

Dynamic range (Difference between the minimum and maximum stimulation)
Existence of sound sensation

Secondary Outcome

Gap detection (recognizable time of two presenting sound)
Thereshold (Minimum stimulation level with sound sensation)
Uncomfortable level (Maximum stimulation level with sound sensation)
Auditory fatigue

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. All patients with hearing loss older than 20 years at the time of informed consent. The type and severity of hearing loss are not exclusion criterion.
2. The patient that a document agreement by the free will of a patient was provided after enough
understanding after having received enough explanation on participating to this study.

Exclude criteria

1. The patient without enough understanding of informed consent.
2. The patient who was examined and found to be wanting by the principal investigator.
3. The patient with contraindication or precaution for electric stimulation
1) The patiens who have or have been treated for arrhythmia.
2) The patient with arhythmia
3)The patient feel pain when the electrode is put on the ear canal

Related Information

• Primary Sponsor: Ganaha Akira
• Secondary Sponsor: Tono Tetsuya
• Source(s) of Monetary Support: Ministry of Education, Culture, Sports, Science and Technology