Audiometric and Surgical Outcomes of a Novel Bone-Conduction Hearing Aid

Abstract

Objective: To report the audiometric and surgical outcomes of a series of patients having undergone implantation of a novel transcutaneous bone conduction implant (t-BCI). Study Design: Retrospective case series. Setting: Single academic tertiary referral center. Patients: Adults (≥18 yr) implanted between December 1, 2019, and August 1, 2021, with audiometric data available before and after device implantation and a minimum of 4 weeks follow-up. Interventions: Surgical t-BCI. Main Outcome Measures: Change in aided pure tone average (PTA) after implantation. Secondary outcomes include average operative time, and adverse events. Results: Twenty-three patients underwent implantation of the t-BCI via either a conventional or minimally invasive surgical approach. The most common indication for implantation was unilateral conductive hearing loss with a history of chronic otitis media. The mean operative time was 59 minutes. The mean preimplantation unaided air conduction PTA was 65 dB, and mean postimplantation was 27.2 dB. The mean change in PTA was 37.8 dB, which was significant ( p < 0.0001). There were 30.4% of the patients that suffered from adverse events, the most common of which were pain (8.7%) and device-related complications (13%). One major adverse event occurred, involving magnet displacement that impaired device activation and required reoperation for replacement. Conclusion: Forming the largest series of patients implanted with this t-BCI in the published literature, our data demonstrate that implantation of the device is feasible via either a traditional or minimally invasive surgical approach, with good audiometric benefit and a favorable safety profile.

Surgical Outcomes of Modified Technique for Transcutaneous Bone Conduction Hearing Aid Implantation

“…Etiologies for hearing loss included: prior history of cholesteatoma resection with continued conductive hearing loss (8), tympanosclerosis (6), single-sided deafness (4), medial canal stenosis (2), congenital mixed hearing loss (2), history of Down syndrome with Eustachian tube dysfunction (2), conductive hearing loss due to lateralization following a lateral graft tympanoplasty (2), prior middle ear malignancy resection (1), and bilateral recurrent tympanic membrane perforations (1). There were three patients that had a prior percutaneous BCHA.…”

“…9,10 Data from early studies show favorable audiometric outcomes compared to either the unaided condition or prior BCHA device in both children and adults. 8,[11][12][13] Typically, this device is implanted by creation of a postauricular soft tissue pocket and is implanted deep to the temporalis muscle, directly overlying the temporal bone. The manufacturer has published a guide for creation of this pocket in the optimal location.…”

“…The OSI200 is the piezoelectric transducer portion of the system, consisting of a circular coil and removable magnet designed to be located more superiorly on the skull as well as a rectangular transducer portion designed to be located more inferiorly, which is connected to the BI300 to complete the vibratory sound transmission system 9,10 . Data from early studies show favorable audiometric outcomes compared to either the unaided condition or prior BCHA device in both children and adults 8,11–13 …”

“…The lack of a percutaneous component decreases the risk of local skin reactions that affect percutaneous models, though the more extensive nature of the implantation procedure introduces further risks such as hematoma/seroma formation, flap failure and dehiscence, device failure, and extrusion. 8 The Cochlear Osia OSI200 Implant (Cochlear Americas, Englewood, CO) is one of these transcutaneous systems. Current indications for this BCHA include conductive or mixed hearing loss (bone conduction pure tone average ≤55 dB HL) or unilateral hearing loss (air conduction pure tone average ≤20 dB in the better hearing ear).…”

“…Transcutaneous systems typically consist of an implanted transducer on the temporal bone as well as an external processor which attaches magnetically. The lack of a percutaneous component decreases the risk of local skin reactions that affect percutaneous models, though the more extensive nature of the implantation procedure introduces further risks such as hematoma/seroma formation, flap failure and dehiscence, device failure, and extrusion 8 …”