The Bonebridge BCI 602 Active Transcutaneous Bone Conduction Implant in Children: Objective and Subjective Benefits

Background: the Bonebridge hearing implant is an active transcutaneous bone conduction implant suitable for various types of hearing loss. It was first launched in 2012 as the BCI 601, with a newer internal part (BCI 602) released in 2019. With the new size and shape, the BCI 602 can be used in patients previously excluded due to insufficient anatomical conditions, especially in patients with congenital defects of the outer and middle ear. Objectives: the purpose of this study is to evaluate the objective and subjective benefits of the new Bonebridge BCI 602 in children who have hearing impairment due to conductive or mixed hearing loss. Safety and effectiveness of the device was assessed. Methods: the study group included 22 children aged 8–18 years (mean age 14.7 years) who had either conductive or mixed hearing loss. All patients were implanted unilaterally with the new Bonebridge BCI 602 implant. Pure tone audiometry, speech recognition tests (in quiet and noise), and free-field audiometry were performed before and after implantation. Word recognition scores were evaluated using the Demenko and Pruszewicz Polish Monosyllabic Word Test, and speech reception thresholds in noise were assessed using the Polish Sentence Matrix Test. The subjective assessment of benefits was carried outusing the APHAB (Abbreviated Profile of Hearing Aid Benefit) questionnaire. Results: after implantation of the Bonebridge BCI 602 all patients showed a statistically significant improvement in hearing and speech understanding. The mean word recognition score (WRS) changed from 12.1% before implantation to 87.3% after 6 months. Mean speech reception threshold (SRT) before implantation was +4.79 dB SNR and improved to −1.29 dB SNR after 6 months. All patients showed stable postoperative results. The APHAB questionnaire showed that difficulties in hearing decreased after implantation, with a statistically significant improvement in global score. Pre-operative scores (M = 35.7) were significantly worse than post-operative scores at 6 months (M = 25.7). Conclusions: the present study confirms that the Bonebridge BCI 602 is an innovative and effective solution, especially for patients with conductive and mixed hearing loss due to anatomical ear defects. The Bonebridge BCI 602 system provides valuable and stable audiological and surgical benefits. Subjective assessment also confirms the effectiveness of the BCI 602. The BCI 602 offers the same amplification as the BCI601, but with a smaller size. The smaller dimensions make it an effective treatment option for a wider group of patients, especially children with congenital defects of the outer and middle ear.

Round Window Stimulation of the Cochlea

Mixed hearing loss associated with a sensorineural component and an impaired conductive mechanism for sound from the external ear canal to the cochlea represents a challenge for rehabilitation using either surgery or traditional hearing amplification. Direct stimulations of the ossicular chain and the round window (RW) membrane have allowed an improved hearing in this population. The authors review the developments in basic and clinical research that have allowed the exploration of new routes for inner ear stimulation. Similar changes occur in the electrophysiological measures in response to auditory stimulation through the traditional route and direct mechanical stimulation of the RW. The latter has proven to be very effective as a means of hearing rehabilitation in a group of patients with significant difficulties with hearing and communication.

Long-term data of the new transcutaneous partially implantable bone conduction hearing system Osia®

Purpose The new active transcutaneous partially implantable osseointegrated system Cochlear™ Osia® System is indicated in case of conductive or mixed hearing loss (CHL/MHL) with a maximum average bone conduction hearing loss of 55 dB, or in single-sided deafness (SSD). The implant directly stimulates the bone via a piezoelectric transducer and is directed by an external sound processor. We conducted a monocentric retrospective longitudinal within-subject clinical study at our tertiary academic referral center. The aim was to investigate long-term data (2017–2021) on audiological outcomes and hearing-related quality of life for the Osia system. Methods Between 2017 and 2020, 22 adults (18: CHL/MHL; 3: SSD) were implanted with the Osia100 implant; seven received bilateral implants. As of 10/2020, the sound processor was upgraded to Osia 2. Results Mean Osia system use by 04/2021 was 30.9 ± 8.6 months (range 17–40 months). Unaided bone conduction thresholds were unchanged postoperatively. One patient had to be explanted because of prolonged wound infection. Aided hearing thresholds were significantly lower compared to the unaided thresholds preoperatively, along with a marked increase in speech recognition in quiet. Speech processor upgrade resulted in a stable benefit. Patients with CHL/MHL and SSD showed a similar improvement in self-rated hearing performance revealed by SSQ, APHAB, and HUI questionnaires. Conclusion The Osia system is a safe, effective and sustainable option for treatment of conductive and mixed hearing loss or single-sided deafness.

Postoperative Benefit of Bone Anchored Hearing Systems: Behavioral Performance and Self-Reported Outcomes

Introduction Bone anchored hearing solutions are a well-known option for patients with a conductive, mixed conductive-sensorineural hearing loss and those with single-sided deafness. Objective The aim of the present study was to evaluate the Ponto bone-anchored hearing system in terms of behavioral performance and self-reported outcomes, by comparing unaided and aided performance (softband and abutment), as well as aided performance with the sound processor on softband (preoperatively) versus abutment (postoperatively). Methods Fourteen adult bone-anchored candidates, with either a bilateral (n = 12) or unilateral (n = 2) conductive or mixed hearing loss, participated in the present study. Sound-field hearing thresholds were evaluated unaided and aided (softband and abutment). A speech-in-noise test was also performed unaided and aided for two spatial configurations (S0N90; implanted side; S0N90; nonimplanted side). The Glasgow Health Status Inventory and the Speech, Spatial and Quality of sound questionnaires were administered pre- and postsurgery to compare quality of life and perceived unaided and aided performance. Skin reaction (Holgers scores) was evaluated at 15 days, 6 weeks, and 10 weeks after surgery. Results Significant improvements postoperatively relative to unaided were obtained for sound-field thresholds at all tested frequencies. Additionally, sound-field thresholds were significantly improved with the sound processor on abutment relative to the softband at frequencies > 1 kHz. Improved performance postoperatively relative to unaided was also obtained in the speech-in-noise test and in self-reported outcomes. Conclusions Improvements in behavioral performance and self-reported outcomes were obtained with the sound processor mounted on abutment.

A Vibrant Soundbridge aktív középfül-implantátum történeti áttekintése és sebészi alkalmazásának lehetőségei

Összefoglaló. A Vibrant Soundbridge aktív középfül-implantátum vezetéses, sensorineuralis és kevert típusú halláscsökkenés esetén is megoldást jelenthet a beteg hallásrehabilitációja során. Sensorineuralis halláscsökkenés esetén akkor indikálható, ha a légvezetéses hallásküszöb nem haladja meg a 80–85 dBHL-t a 3–4 kHz frekvenciákon, vezetéses, illetve kevert típusú halláscsökkenés esetén pedig akkor, ha a csontvezetéses hallásküszöb nem haladja meg a 45–65 dBHL-t a 0,5–4 kHz közti frekvenciatartományban. Az implantátum beültetését eleinte tisztán sensorineuralis halláscsökkenés esetén végezték, és csupán egyféleképpen történhetett: a rezgéskeltő rendszer oldalán lévő rögzítőcsipeszt rá kellett applikálni az incus hosszú nyújtványára. Azokra az esetekre, amikor a rezgéskeltő rögzítése nem kivitelezhető, különböző rögzítőelemeket (coupler) fejlesztettek ki. Az incusra való rögzítés hosszúnyújtvány-couplerrel, illetve rövidnyújtvány-couplerrel lehetséges. Vezetéses és kevert típusú halláscsökkenés esetén a kerek ablak membránjához is illeszthető a rendszer, előrehaladott otosclerosis esetén pedig a Soundbridge-implantáció stapedotomiával kiegészített változata („power stapes”) hozhat kielégítő halláseredményt. Ezek a technikák meglehetősen megnövelték a sebész szabadságát, így széles körben alkalmazott, megbízható megoldássá váltak. A Pécsi Tudományegyetem Fül-Orr-Gégészeti és Fej-Nyaksebészeti Klinikáján az elmúlt évtizedben számos incusvibroplastica történt, de kerekablak-vibroplasticára is több alkalommal sor került. A jelen összefoglaló tanulmányban a Vibrant Soundbridge implantátum technikai fejlődésének történeti áttekintésén felül az alkalmazható műtéti megoldásokat mutatjuk be. Orv Hetil. 2021; 162(40): 1619–1626. Summary. The Vibrant Soundbridge active middle ear implant can provide a reliable solution for hearing rehabilitation of patients with conductive, sensorineural or mixed hearing loss. For sensorineural hearing loss, the air conduction threshold of the patient should not be more increased than 80–85 dBHL at the range of 3–4 kHz, and for conductive and mixed hearing loss, the bone conduction threshold should not be more increased than 45–65 dBHL between 0.5 and 4 kHz. The standard surgical procedure was originally designed for purely sensorineural hearing loss, and the fixation clip of the vibrating transducer needed to be crimped onto the long process of the incus. In many cases, it is impossible to crimp the vibrator onto the incus. In order to solve such circumstances, fixation clips (couplers) have been developed. There are two options to crimp the device on the incus: applying a long process coupler or a short process coupler. For conductive or mixed hearing loss, a round window soft coupler has been introduced. In advanced otosclerotic cases, a special combined technique of Soundbridge implantation with simultaneous stapedotomy can result in sufficient hearing rehabilitation. These techniques significantly broadened the scale of possibilities for the implantation, therefore, it became a widely utilized, reliable procedure. At the Department of Otorhino-laryngology, Clinical Center, University of Pécs, in addition to a noteworthy amount of incus vibroplasty, several cases of round window vibroplasty have also been performed. The aim of the present study is to summarize the history of development of the Vibrant Soundbridge and to present an overview of the applicable surgical techniques. Orv Hetil. 2021; 162(40): 1619–1626.

Middle Ear Ceruminous Gland Adenoma Obstructing the Eustachian Tube Orifice

Ceruminous glands are located in the skin of the cartilaginous portion of the external auditory canal, and ceruminous gland adenoma originating from the middle ear mucosa is extremely rare. We report a case of middle ear ceruminous gland adenoma which caused long-standing otomastoiditis and mixed hearing loss with a large air-bone gap by obstructing the bony Eustachian tube. We discuss the clinical characteristics and histologic features of the present case.

Sneeze-induced pneumolabyrinth 15 years after stapedotomy

Pneumolabyrinth refers to the presence of air within the inner ear and is a fairly common occurrence immediately after stapes surgery, but rarely occurs in a delayed manner years after the initial operation. We present a case of a patient with a history of left stapedotomy 15 years prior, who presented with acute onset vertigo, tinnitus and hearing loss in her operated ear. Her symptoms were preceded by an upper respiratory tract infection associated with bouts of sneezing. Examination revealed a spontaneous right beating nystagmus and positive head thrust to the left. Pure tone audiometry demonstrated a left mixed hearing loss which subsequently deteriorated to a profound sensorineural hearing loss. CT showed the presence of air within the left vestibule and semicircular canals. The patient underwent an exploratory tympanotomy and repair of perilymphatic leak with resolution of vestibular symptoms but no improvement in sensorineural hearing thresholds.