Hearing loss, mainly caused by aging, is a bilateral loss of the function, in which hearing in both ears deteriorates at the same time. Patients with a bilateral hearing loss can attempt a hearing rehabilitation through hearing aids or cochlear implantations that have been sufficiently proved in the effectiveness. Meanwhile, there are also patients with unilateral hearing loss (normal hearing function on the contralateral ear), and the prevalence of the unilateral loss is not negligible, as about 5.7%. Since they have normal hearing on one side, they can manage to maintain their lives; however, their listening ability in a noisy environment is poor. Therefore, when many people have a conversation at the same time, they feel very difficult. Furthermore, due to the decrease in the sense of space, it is difficult to locate the sound.
Nevertheless, most of the patients with unilateral hearing loss do not use any assistive devices. It is known that only 11% of patients use hearing aids. This is thought to be largely due to two reasons. First, the use of hearing aids or other assistive devices for the unilateral hearing loss patients is not covered by the National Health Insurance Service, there are economic burden for them. Second, the effectiveness is often limited. For example, a conventional hearing aid can be used for mild or moderate hearing loss, but it is not effective for patients with severe or profound loss.
As can be easily understood by bone conduction earphones that do not obstruct the ear canal, human can hear sound through the vibrations of the skull. A bone-conduction implant uses this principle and can be a treatment option for the patients. Sound coming from the direction of the impaired ear vibrates the internal device implanted, then this vibration can pass through the skull and enter the inner ear with normal hearing. Therefore, the US FDA suggests a unilateral hearing loss as an indication for the implantable bone-conduction hearing aid. However, in Korea, due to insufficiency of the studies related to this, the implantable bone-conduction hearing aid for unilateral hearing loss are not covered by the national health insurance.
This study aims to investigate the effect of the implantable bone-conduction hearing aid in patients with unilateral hearing loss in Korea. Ultimately, the goal of the study is to present an effective treatment to many patients with who feel uncomfortable in social activities and noisy environments.

Treatment

Implantation of active bone-conduction hearing aid through the surgery.

Arm Label

Target Number of Participant

Arm Type

Arm Description

Implantation of active bone-conduction hearing aid through the surgery.

Gender

Age

Description

(1) Unilateral sensorineural hearing loss patients ≥ 19 years of age
(2) Air-conductive hearing thresholds at the weighted four-frequency (500, 1000, 2000, and 4000 Hz) average ≥ 70 dB and bone-conductive hearing thresholds at the weighted four frequency average ≤ 30 dB
(3) Difficult to expect the improvement of hearing by the use of conventional hearing aids
(4) No contraindication to general or local anesthesia
(5) Subjects must voluntarily consented to participate in the clinical study and signed the consent form.

(1) Those who cannot read the consent form (for example, illiterate or foreigner) or who cannot understand the clinical study due to intellectual disabilities
(2) If the hearing loss period is short and there is a possibility of spontaneous recovery, such as sudden sensorineural hearing loss
(3) If a subject is being administered a drug that may affect the hearing or has a systemic disease that may cause hearing impairment
(4) Judged to be inappropriate for this clinical study by the investigators of the study

Pure-tone thresholds

Preoperatively, at 1 month after the use of the hearing aid, and at 3 month after the use of the hearing aid

Speech discrimination score

Preoperatively, at 1 month after the use of the hearing aid, and at 3 months after the use of the hearing aid

Bern Benefit in Single-Sided Deafness questionnaire (BBSS)

Preoperatively and 3 months after the use of the hearing aid

Abbreviated Profile of Hearing Aid Benefit (APHAB)

Preoperatively and 3 months after the use of the hearing aid

Tinnitus Handicap Inventory (THI)

Preoperatively and 3 months after the use of the hearing aid

Hantai Kim, Moo Kyun Park, Shi Nae Park, Hyong-Ho Cho, Jae Young Choi, Chi Kyou Lee, Il-Woo Lee, Il Joon Moon, Jae Yun Jung, Jinsei Jung, Kyu-Yup Lee, et al.. Efficacy of the Bonebridge BCI602 for Adult Patients with Single-sided Deafness: A Prospective Multicenter Study. Otolaryngology-Head and Neck Surgery. SCI. 2024-02-01 ,
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														https://doi.org/10.1002/ohn.520
														

The mean aided pure-tone threshold was 34.2 (11.3), mean (SD), dB HL at 500 to 4000 Hz. The mean total BBSS score was 27.5 (13.8). All APHAB questionnaire domain scores showed significant improvements: ease of communication, 33.6 (23.2) versus 22.6 (21.3), P = .025; reverberation, 44.8 (16.6) versus 32.8 (15.9), P = .002; background noise, 55.5 (23.6) versus 35.2 (18.1), P < .001; and aversiveness, 36.7 (22.8) versus 25.8 (21.4), P = .028. Moreover, the THI scores were significantly reduced [47.4 (30.1) versus 31.1 (27.0), P = .003]. Congenital SSD was a significant factor of subjective benefit (−11.643; 95% confidence interval: −21.946 to −1.340). The BCI602 active transcutaneous BCI device can provide functional hearing gain without any adverse effects and is a feasible option for acquired SSD patients with longterm deafness.