Long-term hearing performance and soft tissue outcomes of Baha@ Attract system in patients with bilateral congenital microtia in a single center

Abstract： Background: Baha Attract System was designed as non-skin penetrating bone conduction implant to minimize skin complication. However, there were insufficient studies on its long-time acoustic outcome and safety in microtia patients with auricle reconstruction surgeries, who have thinner retroauricular subcutaneous layer and theoretically vulnerable skin at the implant side. Objectives: To analysis the long-term hearing performance and soft tissue complications of Baha@ Attract System in microtia population. Study Design & setting: A prospective cohort study at single tertiary referral center. Patients: Twenty Mandarin-speaking patients with congenital bilateral microtia who were underwent Baha@ Attract implantation with or without auricle reconstruction surgeries simultaneously. Main Outcome Measure(s): Comparative analysis of audiological test results including hearing thresholds and speech recognition in quiet and in noise were pre- and post-operatively performed. subjective benefit as measured with the SSQ Scale. Soft tissue outcomes were monitored and documented. Results: The mean follow-up time was 36.11±3.30 months. Significant and stable improvements in hearing threshold and speech understanding in noise and quiet were demonstrated with aided condition. Subject evaluation revealed high level of patients’ satisfaction with the amplification in all the subscales. Adverse events including skin necrosis increased after one year post-operatively. Soft tissue evolution including sin thinning, erythema, epidermis atrophy, soft tissue atrophy, skin necrosis was seen or once developed in most of the participants. However, prevalence of severe soft tissue complication was not higher to non-microtia population. Conclusions: Baha@ Attract System provides favorable and stable hearing improvements for microtia patients. Combining plastic surgeries with implantation will not increase the prevalence of soft tissue complication. However, long-term soft tissue problems should be highly aware of even after one year post implantation. Key words: Baha Attract, microtia, hearing, soft tissue, skin necrosis

Resultados audiológicos y de calidad de vida en pacientes con transición del sistema Baha Connect® a Baha Attract®

Introducción: los implantes auditivos de conducción ósea percutáneos han sido usados de forma exitosa. Sin embargo, un número importante de pacientes reportan reacciones en piel repetitivas. Los implantes auditivos transcutáneos son una alternativa que pueden solventar estas complicaciones. Con este estudio queremos describir los resultados audiológicos y de calidad de vida en pacientes que requirieron transición del sistema percutáneo a transcutáneo.Metodología: estudio observacional descriptivo, se incluyeron pacientes con implante auditivo percutáneo que requirieron transición a sistema transcutáneo. Se evaluó el desempeño auditivo utilizando una prueba con fondo ruidoso y se aplicó la escala de calidad de vida “Glasgow Benefit Inventory”-GBI.

Baha Attract Implantation Using a Small Incision: Initial Report of Surgical Technique and Surveillance

Objectives. To determine the appropriate anatomical borders of implantation on the temporal bone in a cadaver study, and to develop a simplified surgical technique for Baha Attract implantation through a small incision along the hairline using anatomical evidence and a navigation system.Methods. In a cadaver study, 20 human adult dry skulls were used to find flat areas of the temporal bone for Baha Attract magnet implantation. Four borders of the “optimal surgical site” were defined: Asterion line, occipitomastoid suture line, sigmoid sinus line, and digastric groove line. In three patients, we implanted the Baha Attract according to the newly developed surgical procedure and validated the feasibility of this technique with a navigation system.Results. We identified the appropriate position of the implant on the temporal bone, suggesting a simplified surgical technique for Baha Attract with a small incision. We determined the spot of implantation, and the implants were inserted through a small surgical incision (<2.5 cm) under local anesthesia; the procedure lasted approximately 30 minutes.Conclusion. The optimal surgical site of the temporal bone is a safe and easily accessible location for implantation of the Baha Attract.

Minimal invasive pocket technique for magnet bone implant hearing aid without fixation

Introduction The BAHA (bone-anchored hearing aid) Attract is a magnetic transcutaneous bone conduction device anchored into the temporal bone. The standard surgical technique for BAHA Attract is a multi-tools time-consuming process, which requires a large cutaneous incision. The objective of this study is to describe and test the feasibility of a minimally invasive pocket (MIP) technique for Magnet Bone Implant Hearing Aid (MBIHA) with a modified magnet of BAHA Attract without fixation and without any tissue reduction. We use a 3-cm vertical skin incision and a subperiosteal pocket. Method A study of 10 patients with conductive or mixed hearing loss who benefited from a MBIHA using the MIP technique is presented. The pure tone average (PTA) (dB) for air-conduction thresholds and the speech recognition threshold (SRT) (dB) in speech audiometry in quiet are calculated. The Entific Medical Systems (EMS) questionnaire and the postoperative clinical outcomes are realized. Results We found a significant improvement of 33.8 dB on average for the PTA and 44.8 dB for the SRT with MBIHA at 3 months, compared with unaided situation. No implant was removed or displaced after 2 years of follow-up. The skin condition remains intact in all the cases. Conclusion The minimally subperiosteal pocket surgical technique MIP without fixation and with tissue preservation for the MBIHA is safe, rapid and effective for patients with conductive or mixed hearing loss. It opens new perspectives of development and modify conventional concept in magnetic coupling of bone-conducted device.

Audiological outcomes utilizing a transcutaneous ossseointegrated implant system in pediatric patients

Background: Percutaneous bone conduction hearing aids have proven to be audiometrically successful, but too often result in soft tissue issues at the abutment site. To counter this possibility, a magnetized, transcutaneous bone conduction hearing aid has been developed, the Baha Attract®. However, only limited research exists to demonstrate efficacy and verification measures of the Baha Attract® System. Purpose: The purpose of this study was to evaluate audiologic outcomes when using the Baha Attract® magnetic osseointegrated system in pediatric patients by measuring functional gain and post-implant user satisfaction with the Children’s Home Inventory for Listening Difficulties (CHILD) scale. Research design: The authors used a retrospective chart review of pediatric patients implanted with the Attract® System from 2014 to 2017 at Cook Children's Medical Center located in Fort Worth, Texas. Study sample: One ear of fourteen pediatric patients aged 5 to 18 years with bilateral or unilateral conductive hearing loss implanted unilaterally (13 children) or bilaterally (1 child, 1 ear randomly chosen for inclusion) with the Cochlear Baha Attract® System. Data collection and analysis: Aided and unaided thresholds were collected for 14 patients. Effective gain testing occurred approximately three months after the initial fitting appointment. Additionally, results of the CHILD survey were collected from seven of these children. A 2-factor analysis of variance test was used to examine the audiometric data, descriptive statistics were employed for the CHILD scores and correlations were run between CHILD scores and 1) overall functional gain, 2) frequency-specific functional gain and 3) age. Results: Participants in this study showed a statistically significant improvement in bone conduction thresholds at 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz when using the Baha Attract® System compared to the unaided condition. CHILD survey results showed a mean score of 6.5 and median score of 7 on a scale of 8. Correlation R values ranged from 0.14 to 0.79. Conclusion: For these children with conductive losses, a transcutaneous, magnetic osseointegrated hearing implant is a viable treatment option that provides significant audiometric functional gain. The CHILD results suggest that the children positively benefit from the implant, and that the perceived benefit may increase with age.