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

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

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From April 2019 to November 2021, the electrical promontory stimulation test (PST) using a portable peripheral nerve stimulator (PNS7000) was performed with both the ear canal silver ball electrode (silver ball group) and the newly developed earplug type electrode (earplug group) in 21 ears of 13 patients (7 males, 6 females, age range 29-85 years mean age 61.5 years) with hearing loss. The hearing loss etiologies are as follows (Idiopathic sensorineural deafness 16ears, Otosclerosis 3 ears, Acoustic tumor 1 ear, Cochlear nerve hypoplasia 1ear).

One patient was enrolled in the first year, eight in the second year, and four in the third year. This study was extended for a year because the number of subjects were not achieved to target caused by pandemic of COVID-19.

No adverse events of the PST were identified in all participants.

1. The proportion of patients with sound sensation Sound sensation was elicited in 18 ears (85.7%) and 17 ears (81%) in silver ball group with the stimulation pulse of 50Hz and 100Hz, respectively. Meanwhile, sound sensation was elicited in 10 ears (47.6%) and 9 ears (42.9%) in earplug group with the stimulation pulse of 50Hz and 100Hz, respectively. Chi-square test was conducted and no significant differences were expected in the proportion of patients with sound sensation between silver ball group and earplug group due to the small subjects of 21 ears. 2. Correlation between silver ball group and earplug group in Thr, MCL, UCL and DR The measurement items (Thr, MCL, UCL, and GAP) were evaluated a normal distribution using Shapiro-Wilk statistical analysis. Pearsons correlation coefficient was used in the measurement items with normal distribution (50Hz MCL, DR, 100Hz Thr, MCL, UCL). Spearmans rank-order correlation coefficient analysis were performed in others (50Hz Thr, UCL, 100Hz DR). No significant correlation between the results of silver ball group and earplug group were identified in all measurement items. 3. Correlation between the silver ball group and earplug group in gap detection test The GAP was assessed by presenting two 100 Hz signals below the MCL with an initial gap interval of 10 ms. This interval was measured using both ascending method and descending method. Spearmans rank-order correlation coefficient showed no significant linear correlation between the results of silver ball group and earplug group. 4. Auditory fatigue In the 21 ears, auditory fatigue was evaluated in 20 ears (95%) and 10 ears (48%) in silver ball group and earplug group, respectively. We conducted a Chi-square test and no significant differences were expected in the proportion of participants with auditory fatigue test between the silver ball group and earplug group due to the small subjects. In the results cited above, the results of silver ball group and earplug group agreed 60% of the time.

The proportion of patients with sound sensation in PST using PNS7000 with silver ball electrode was equivalent to the results of prior study using promontory stimulator. Meanwhile, the proportion of patients with sound sensation in the PST using earplug type electrode was less than the proportion of patients using silver ball electrode. In addition, there were no correlation between the results of PST using silver ball group and earplug group in all measured items.

Nov. 30, 2022

No

None.

https://jrct.mhlw.go.jp/latest-detail/jRCTs072190004

Ganaha Akira

University of Miyazaki Hospital

5200 Kiyotakecho Kihara, Miyazaki-city, Miyazaki, Japan

ganaha.akira.t8@cc.miyazaki-u.ac.jp

Ganaha Akira

University of Miyazaki Hospital

5200 Kiyotakecho Kihara, Miyazaki-city, Miyazaki, Japan

+81-985-85-2966

ganaha.akira.t8@cc.miyazaki-u.ac.jp

Complete

April. 01, 2019

Interventional

non-randomized controlled trial

open(masking not used)

no treatment control/standard of care control

single assignment

diagnostic purpose

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.

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

Both

hearing loss

none

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

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

+81-985-85-9403

Mar. 29, 2019

none