A New Transcutaneous Bone Conduction Hearing Implant (original) (raw)
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The bone conduction implant – a review and 1-year follow-up
International Journal of Audiology, 2019
Objective: The objective of this study is to evaluate its safety and effectiveness of the bone conduction implant (BCI) having an implanted transducer and to review similar bone conduction devices. Design: This is a consecutive prospective case series study where the patients were evaluated after 1, 3, 6 and 12 months. Outcome measures were focussed on intraoperative and postoperative safety, the effectiveness of the device in terms of audiological performance and patient's experience. Study sample: Sixteen patients with average age of 40.2 (range 18-74) years have been included. Thirteen patients were operated in Gothenburg and three in Stockholm. Results: It was found that the procedure for installing the BCI is safe and the transmission condition was stable over the follow-up time. No serious adverse events or severe adverse device effects occurred. The hearing sensitivity, speech in noise and the self-assessment as compared with the unaided condition improved significantly with the BCI. These patients also performed similar or better than with a conventional bone conduction reference device on a softband. Conclusions: In summary, it was found that the BCI can provide a safe and effective hearing rehabilitation alternative for patients with mild-to-moderate conductive or mixed hearing impairments.
Three-Year Follow-Up with the Bone Conduction Implant
Audiology and Neurotology, 2020
Background: The bone conduction implant (BCI) is an active transcutaneous bone conduction device where the transducer has direct contact to the bone, and the skin is intact. Sixteen patients have been implanted with the BCI with a planned follow-up of 5 years. This study reports on hearing, quality of life, and objective measures up to 36 months of follow-up in 10 patients. Method: Repeated measures were performed at fitting and after 1, 3, 6, 12, and 36 months including sound field warble tone thresholds, speech recognition thresholds in quiet, speech recognition score in noise, and speech-to-noise thresholds for 50% correct words with adaptive noise. Three quality of life questionnaires were used to capture the benefit from the intervention, appreciation from different listening situations, and the ability to interact with other people when using the BCI. The results were compared to the unaided situation and a Ponto Pro Power on a soft band. The implant functionality was measured...
Complications of bone-anchored hearing aids in pediatric patients
International Journal of Pediatric Otorhinolaryngology, 2011
Bone-anchored hearing aids (Baha 1) were first trialled in 1977 in Goteborg Sweden. The first report in children was not until 1984. These devices are being used with increasing frequency to treat conductive hearing loss in children, most often for aural atresia of the external auditory canal but also for chronic otitis media and unilateral profound sensorineural hearing loss. Multiple studies have shown excellent hearing outcomes, improved quality of life and high device use rates [1-5]. An osseointegrated titanium implant is used for attachment of the device directly to the skull. Chronic inflammation and infection can develop at the interface of the implant with the soft tissue and skin. Even in clinically non-inflamed tissue surrounding the Baha 1 , immunohistochemical studies have shown an increased number of chronic inflammatory cells such as polymorphonuclear cells and Tlymphocytes [6]. Recurrent infection, soft tissue or bone overgrowth, and extrusion of the implant have been reported in the literature with variable frequency [3,5,7-11]. Our anecdotal experience had been that our patients have a high rate of soft tissue reaction and infection requiring recurrent treatment including revision surgery. This study was undertaken to better characterize the rate of these complications and to identify potential risk factors for worse outcomes. 2. Methods Institutional review board and ethics approval were obtained prior to initiation of this study. Data from all children who underwent bone-anchored hearing aid surgery at Starship Children's Hospital from 2002 to 2009 were retrospectively collected from their medical records. Age at surgery, age at follow up, gender, ethnicity, indication, pertinent history, soft tissue complications, date of complications, abutment removal/replacement, any required treatment, failure of osseointegration, device failure, and device use were studied. Socioeconomic status and weight data were also collected. Based on the patient's address, a New Zealand Deprivation Index 2006 (NZDep2006) was identified for each patient. This was used as an indicator of socioeconomic status and is based on Census
Audiologic and Surgical Outcomes of a Novel, Nonpercutaneous, Bone Conducting Hearing Implant
Otology & Neurotology, 2013
Objective: To assess the selection criteria, surgical technique, audiologic, and quality of life outcomes for a novel, nonpercutaneous bone conductor hearing aid. Study Design: Retrospective case review. Setting: Secondary otology practice. Patients: Eighteen patients (16 adults and 2 children). Intervention: Implantation of unilateral (n = 16) or bilateral (n = 2) devices. Main Outcome Measures: Mean preoperative and postopera tive air conduction and bone conduction free-field testing, BKB-SIN aided and unaided at 0-degree 70 dB SPL, Speech, Spatial, and Qualities of Hearing Scale (SSQ), aided and unaided measures of localization and discrimination in single-sided deafness (SSD), surgical complications. Results: Implants have been fixed under general or local anesthesia without perioperative complications. Two patients noted minor skin irritation only. Audiologic gain was greatest for those with bilateral conductive loss (21.9 T 10.4 dB HL). For those with bilateral and unilateral mixed loss, gain was 6.2 T 5.3 dB HL and 5.5 T 6.5 dB HL, respectively. A greater improvement was seen with BKB-SIN at 70 dB SPL at 0 with all groups except for SSD, gaining statistically significant benefit. Localization and discrimination studies in patients with SSD or unilateral conductive loss failed to detect benefit from aiding. SSQ scores show an improvement in all domains for each patient group. Conclusion: The surgical procedure requires no specialized equipment and can be performed as a day case. This device complements treatment for patients requiring bone conduction aids and presents as an alternative to conventional percutaneous bone-anchored implants.
First experiences with a new adhesive bone conduction hearing device in children
International Journal of Pediatric Otorhinolaryngology, 2019
To evaluate the hearing benefit, advantages, and disadvantages in a series of children using a new, nonimplantable, pressure-free, adhesive bone conduction hearing aid. Methods: Seventeen children were included in the study. 5 children suffered from bilateral conductive hearing loss (CHL), 6 children with unilateral CHL and 6 children with unilateral sensorineural hearing loss. An audiological tests were provide. Additionally, sound quality (SSQ10) and quality of life (AQoL-6D) were assessed using questionnaires. Results: The average value of speech audiometry with bubble noise in children with SNHL is 21.33 (± 5.72) dB HL with the device and 27.67 (± 4.59) dB HL without the device, which is a statistically significant gain (p = 0.027). The analysis showed the average value of hearing threshold in sound field in the group of children with CHL supported 20.23 (± 16.84) dB HL and not supported 33.52 (± 27.27) by the hearing aid for bone conduction, which i a statistically significant gain (p = 0.008). The average value of speech audiometry is 23.45 (± 14.45) dB HL with the device and 37.27 (± 26.65) dB HL without the device, which is a statistically significant gain (p = 0.012). The average value of speech audiometry with bubble noise is 30.55 (± 10.03) dB HL with the device and 45.45 (± 18.41) dB HL without the device, which is a statistically significant gain (p = 0.008). No patient referred pain or irritation. Conclusion: This new device for bone conduction show a hearing benefit for a paediatric patient, without any concomitant aesthetic and other complications.
The Bone Conduction Implant—First Implantation, Surgical and Audiologic Aspects
Otology & Neurotology, 2014
Objective: To report on preoperative assessment, surgery, and audiologic outcome of the first patient implanted with the bone conduction implant (BCI). Background: The BCI is a bone conduction hearing device with an intact skin solution where the transducer is implanted close to the ear canal opening. By avoiding a percutaneous screw attachment to the skull, the BCI is anticipated to reduce complications associated with the Bone-Anchored Hearing Aid (BAHA) solution. Methods: The first patient to receive a BCI was a 42-year-old woman with a unilateral mixed hearing loss due to tympanosclerosis. Preoperative and postoperative cone beam computed tomography and a virtual planning tool for 3D reconstruction were used to optimize and control the position of the BCI in the mastoid. The transducer was placed in a 5-mm deep seating in the mastoid and secured with a titanium bar. Free field tone and speech audiometry were conducted to evaluate the audiologic outcome at baseline (1 month postoperatively) and 1 month after baseline. Results: The BCI was placed in the position according to the preoperative 3D planning. On average, the tone thresholds improved by 30 dB, speech reception thresholds by 25.5 dB and speech signal-to-noise ratio by 9.7 dB. The surgical procedure was considered simple and safe. Conclusion: The BCI can be implanted by a safe and easy surgical procedure. 3D preoperative planning can be helpful to optimize the BCI position. The BCI is a realistic alternative to the BAHA.
Experience of bone-anchored hearing aid implantation in children younger than 5 years of age
International Journal of Pediatric Otorhinolaryngology, 2015
To assess the practicality and benefit of Bone-anchored hearing aid (BAHA 1) implantation in children younger than 5 years of age. FDA approval for use of BAHA 1 only exists for children 5 years of age and older. Their use in Australia is also rare, however their use for younger children is approved by the European Union. We wish to share our experience of implantation in an antipodean setting in this age group. Methods: Institutional board approval was obtained for this study. All children undergoing BAHA 1 implantation under 5 years old were included from our prospective database. We examined the variety of surgical techniques, (including skin grafting, limited soft tissue reduction and no soft tissue reduction), BAHA 1 implants and abutments used, and use of the new series 400 hydroxyapatite coatings. Demographic data obtained included age at surgery, follow up duration, gender, ethnicity and indication for surgery. Anonymous benefit questionnaires (Glasgow children's benefit inventory (GCBI) and parents' evaluation of aural performance of children (PEACH)) were completed online as well as a questionnaire on device use. Complications recorded included soft tissue reactions, implant loss/ removal, abutment replacement/removal. We also assessed whether patient weight, ethnicity or socioeconomic status were risk factors for these complications. Results: 24 Children (26 ears/26 implants) under five years were identified from the database and included in the study. There was a 14:10 male to female ratio. Patient caregivers reported subjective benefit and improved quality of life (QOL) despite setbacks and complications related to BAHA 1 usage. 10/24 (42%) of children required treatment for significant peri-implant skin reactions whilst 25% required replacement of their abutments and/or implants. An increased risk of major complication was associated with socioeconomic deprived backgrounds and in patients of New Zealand Maori and Pacific Island ethnicity but not in patients with increased weight centiles. Conclusions: The BAHA 1 implant and hearing aid system is of value to children under age 5 years. Parents tolerate the skin reactions and complications because of the perceived benefit in hearing and quality of life. Careful counselling of parents of potential young BAHA 1 implant candidates is necessary in light of this.
Archives of Otolaryngology–Head & Neck Surgery, 1998
To compare the percutaneous boneanchored hearing aid (BAHA; type NBC-HC-200, Nobel Biocare, Gothenburg, Sweden) and the transcutaneous temporal bone stimulator (TBS; Xomed-Treace, Jacksonville, Fla) with conventional hearing aids and to evaluate long-term results. Design: In a prospective clinical study, the new implantable bone-conduction devices were compared with the patients' previous conventional hearing aids. Speech perception in quiet and in noise were studied, and a questionnaire concerning the actual use of the device and speech recognition was administered. During follow-up that exceeded 4 1 ⁄2 years, relevant technical and medical problems were documented. Patients: Forty-one successive subjects who were fitted with a BAHA and 17 subjects who were fitted with a TBS. Results: In most subjects who had previously used a bone-conduction device, the new BAHA and TBS devices led to improved or comparable results on speech recognition tests and the questionnaire. However, among the subjects who had previously used air-conduction hearing aids, the results were ambiguous. In the long-term, the percentage of nonusers in the BAHA group was 5% (2/39); in the TBS group, 65% (13/20). The main reasons for not using the TBS were insufficient gain and medical and technical problems. The vulnerability of the percutaneous coupling of the BAHA to trauma or inflammation was not a major issue; only 4 implants were lost during the total follow-up of more than 250 years. Conclusion: Results indicate that the BAHA is the better choice.
In patients with conductive hearing loss caused by middle ear disorders or atresia of the ear canal, a Bonebridge implantation can improve hearing by providing vibratory input to the temporal bone. The expected results are improved puretone thresholds and speech recognition. In the European Union, approval of the Bonebridge implantation was recently extended to children. We evaluated the functional outcome of a Bonebridge implantation for eight adults and three children. We found significant improvement in the puretone thresholds, with improvement in the air-bone gap. Speech recognition after surgery was significantly higher than in the best-aided situation before surgery. The Bonebridge significantly improved speech recognition in noisy environments and sound localization. In situations relevant to daily life, hearing deficits were nearly completely restored with the Bonebridge implanta-tion in both adults and children.
The bone conduction implant: Clinical results of the first six patients
International Journal of Audiology, 2015
There is a rapidly growing interest in different bone conduction devices (BCD) available for hearing-impaired patients. Since the end of the 1970s, the bone-anchored hearing aid (BAHA) is a common choice of hearing rehabilitation for patients with mild-to-moderate conductive and mixed hearing loss. Today more than 150 000 patients have been treated with this percutaneous solution (Cochlear, 2013; Oticon Medical, 2014). However, due to some complications related to the skin penetration of the traditional BAHA titanium abutment (Dun et al, 2012; Kiringoda & Lustig, 2013; Snik et al, 2005), a trend is seen towards transcutaneous devices (both passive and active), characterized by the most important feature of keeping the skin intact. A passive transcutaneous device, which is a skin drive device, uses implanted magnet(s) for the attachment of an external audio processor (AP) on the head over the implant. The AP incorporates the transducer, which transmits vibrations through the skin before vibrating the bone. Available passive transcutaneous devices on the market are Sophono Alpha (Sophono ™ , Boulder, USA) and Baha ® Attract (Cochlear ® BAS, M ö lnlycke, Sweden). An active transcutaneous device, which is a direct drive device, has an implanted transducer in direct contact to the bone, and here only the AP (without transducer) is attached on the intact skin via retention magnets. Currently, there is one active transcutaneous bone conduction device available on the market, Bonebridge ™ (MED-EL, Innsbruck, Austria), while the present bone conduction implant (BCI), developed in cooperation between research groups at