Otology & Neurotology 00:00Y00 2008, Otology & Neurotology, Inc.

Successes and Complications of the Baha System

*Jack J. Wazen, *Dayton L. Young, *Matthew C. Farrugia, Sujana S. Chandrasekhar, Soha N. Ghossaini, Julia Borik, Christian Soneru, and Jaclyn B. Spitzer
*The Silverstein Institute, Ear Research Foundation, Sarasota, Florida; and Department of Otolaryngology, Mount Sinai School of Medicine, and Department of OtolaryngologyVHead and Neck Surgery, Columbia University College of Physicians and Surgeons, New York, New York, U.S.A.

Objective: To determine the incidence and type of complications, as well as patient satisfaction, associated with the Baha system. Study Design: Retrospective case review. Setting: The Silverstein Institute, Sarasota, Florida, and the Columbia University Medical Center, New York, New York. Patients: Patients with conductive/mixed hearing loss and singlesided deafness implanted with the Baha system between June 1998 and December 2007. Intervention: Implantation with the Baha system. Main Outcome Measure: Incidence and type of complications associated with Baha implantation and patient satisfaction as measured by a questionnaire administered on site or by telephone. Results: In our series of 218 patients (223 ears), there were no major complications. Of these patients, 4.5% required revision

surgery for soft tissue complications and 1.3% needed revision for failure of osseointegration. Eight percent (8%) required local care and resolved within 2 to 3 weeks of treatment. Five percent (5%) required in office procedures. One hundred six (106) patients satisfactorily completed the survey questionnaire. Ninety-two percent (92%) reported using the device regularly and 77% were happy with the device. On average, patients reported using the device 10.1 h/d, 5.6 d/wk. Conclusion: The Baha system is safe and effective in the rehabilitation of patients with conductive or mixed hearing losses and with single-sided deafness. The high success rate, patient satisfaction rate, and predictable auditory outcome place the Baha among the leading choices for auditory rehabilitation. Key Words: ComplicationVPatient satisfactionVSoft tissue. Otol Neurotol 00:00Y00, 2008.

Since the first application of titanium implants in the temporal bone in 1977 (1), the Baha system has become a well-established and successful method of auditory rehabilitation. Initially described for the treatment of conductive and mixed hearing losses, the Baha system is now also used in cases of single-sided deafness, such as acoustic neuroma or sudden sensorineural hearing loss (2,3). Initial concerns of a percutaneous abutment and its potential for complications have been alleviated by a reproducible success rate, high patient satisfaction, and the lack of serious complications. The purpose of this paper was to review our experience with the Baha system and to report our incidence of success, failure, and complications.

METHODS
This is a retrospective chart review of patients implanted with the Baha system at the Columbia University Medical Center and the Silverstein Institute between June 1998 and December 2007. After obtaining institutional review board approval from both facilities, the medical charts were obtained and reviewed. The patients demographics, diagnosis, procedure date, activation date, and postoperative reactions and complications were recorded and tabulated. Major complications were defined as those complications requiring inpatient hospital care or with associated significant morbidity such as meningitis, brain abscess, osteitis, or acute mastoiditis. Minor complications were divided into complications requiring minimal office treatment and complications requiring revision ambulatory surgery. Patients with complete information were next contacted by telephone or were interviewed on site, and a patient satisfaction questionnaire was administered (Table 1).

RESULTS
Address correspondence and reprint requests to Jack J. Wazen, M.D., The Silverstein Institute, Ear Research Foundation, Sarasota, Florida; E-mail: jwazen@silversteininstitute.com

Two hundred eighteen (218) patients implanted between June 1998 and December 2007 were identified. 1

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TABLE 1.
1. 2. 3. 4.

J. J. WAZEN ET AL.
Patient satisfaction questionnaire TABLE 3. Etiology of hearing loss in 113 patients implanted for single sided deafness
n 48 27 23 6 3 7 114 % 42.1 23.7 20.2 5.3 2.6 6.1 100

Are you using your Baha on a regular basis? How many days per week do you use your device? How many hours per day do you use your device? Has your quality of life improved?

Cause of hearing loss Sudden sensorineural hearing loss Acoustic neuroma/cranium base tumor resection ` Menieres disease Congenital Trauma Other Total

For situations 4 to 12, try to determine your level of satisfaction on a 10-point scale (1 = extremely displeased, 10 = extremely pleased) 5. Talking with one individual in a quiet situation? 6. Talking with one individual among a group? 7. Listening to music? 8. Listening to TV or radio? 9. At a dinner table? 10. How satisfied are you with the aesthetics? 11. How do you find the handling of the device? 12. Locating from where a sound is coming? 13. Overall satisfaction?

Five patients underwent bilateral implantation resulting in 223 implanted ears. One hundred fourteen (114) patients were implanted for single-sided deafness and 104 patients (109 ears) were implanted for conductive hearing loss. There were 96 (44%) men and 122 (56%) women. The age ranged between 6 and 92 years. The mean age was 56.5 years. The mean follow-up period was 44 months (3.67 yr) and ranged from 4 to 114 months (9.5 yr). The causes of hearing loss for which patients underwent the Baha procedure are shown in Tables 2 and 3. The most common indication for the Baha procedure in this series was chronic otitis media. Sixty-five (65) patients were implanted with a Baha for either chronic external otitis or conductive hearing loss resulting from the sequelae of chronic otitis media. The second most frequent cause of conductive hearing loss, for which patients underwent the Baha procedure, was congenital aural atresia (30 patients). Other, less frequent causes of conductive/mixed hearing loss, for which patients underwent the Baha procedure, included otosclerosis and patients who underwent resection of tumors involving the temporal bone (4 patients). In patients implanted for single-sided deafness, the most frequent indication was sudden sensorineural hearing loss (48 patients). The next most frequent cause of single-sided deafness, for which patients were implanted, included patients with unilateral cerebellopontine angle and cranium base tumors (27 patients), followed closely by patients with unilateral deafness caused by the se ` quelae of Menieres disease (23 patients). Other less common causes of single-sided deafness, for which
TABLE 2. Etiology of hearing loss in 105 patients implanted for conductive hearing loss
n 65 30 5 4 104 % 62.5 28.8 4.8 3.8 100

patients were implanted, included congenital singlesided deafness, trauma, and autoimmune inner ear disease. In our series of 218 patients (223 ears), there were no major complications. Most of the complications (13%) were minor, requiring only local care (8%) or minor in-office procedures (5%). Of the 18 minor complications requiring only local care, 8 (44%) occurred within 4 weeks of surgery, 5 (28%) occurred within 2 to 3 months of surgery, 3 (17%) occurred within 6 months of surgery, 1 (6%) occurred within 3 years of surgery, and 1 (6%) occurred within 6 years of surgery. Of the 11 minor complications requiring in-office procedures, 2 (18%) occurred within 1 week of surgery, 1 (9%) occurred within 1 month of surgery, 7 (64%) occurred within 6 months of surgery, and 1 (9%) occurred within 3 years of surgery. All but one of these minor complications resolved within 2 to 3 weeks of initiation of treatment. One patient had undergone radiation therapy for maxillary sinus cancer. The patients flap healed within 6 weeks. In addition to the minor complications described above, requiring only local care or in office procedures, 4.5% of implanted ears required revision surgery for soft tissue complications and 1.3% needed revision for failure of osseointegration (Tables 4Y6). These patients underwent revision surgery between 9 months and 2 years after the initial Baha placement. There were only four patients with immediate postoperative complications. One patient developed a hematoma, which required incision and drainage in the office. Another developed an abscess, which also required an in-office incision and drainage. A third patient had postoperative bleeding, requiring a revision to the patients pressure dressing, and another had a partial flap dehiscence that healed with local care. The most common postoperative complication was local tissue inflammatory reactions, which ranged from
TABLE 4.
Complication Cellulitis/granulation/infection Dermatitis/skin reactions Pain/neuralgia Immediate postoperative complications (e.g., bleeding/dehiscence) Total

Minor complications requiring local care in 223 implanted ears

n 10 3 3 2 18 % 4.5 1.3 1.3 0.9 8.1

Cause of hearing loss Chronic otitis Congenital aural atresia Otosclerosis Tumor Total

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SUCCESSES AND COMPLICATIONS OF THE BAHA SYSTEM

TABLE 5. Minor complications requiring in-office procedures in 223 implanted ears
Complication Keloid formation requiring kenalog injection Skin overgrowth/granulation requiring excision Incision and drainage of abscess/hematoma Need for longer abutment Total n 4 4 2 1 11 % 1.8 1.8 0.9 0.4 4.9

TABLE 7.
Questionnaire item 1. 2. 3. 4. 5. Life improved? Using device Not using device Mean use (d/wk) Mean use (h/d)

Overall patient satisfaction/device use

SSD (n = 61) 46 (75%) 57 (93%) 4 (7%) 5.4 9.6 CHL (n = 45) 36 (80%) 41 (91%) 4 (9%) 5.8 10.6 Overall (n = 106) 82 (77%) 98 (92%) 8 (8%) 5.6 10.1

SSD indicates single sided deafness; CHL, conductive/mixed hearing loss.

very mild cases of local dermatitis and cellulitis to formation of granulation tissue and, in some cases, hypertrophic skin overgrowth and scarring. In our series, 3 patients developed cases of local dermatitis thought to be secondary to eczema or skin reaction to the antibiotic ointment. Ten patients (4.5%) presented with cellulitis requiring topical antibiotics and local care. Other minor postoperative complications included 3 patients who developed local postoperative neuralgia. Postoperative complications requiring in-office procedures include four patients with keloid formation requiring kenalog injections and four patients with skin overgrowth requiring in-office excision to re-expose the abutment. The kenalog injections were started at approximately 6 months postoperatively, and treatment consisted of 3 weekly injections of kenalog (40 mg/ml). The patients treated with in-office excision had localized skin irritation that was deemed to be resectable under local anesthesia. Patients with more florid skin reactions, such as patients with skin overgrowing the implant and requiring extensive dissection, or patients with extensive hypertophic scar formation, were taken to the operating room as described above. Of 218 patients, 107 could be reached to participate in the survey questionnaire. One hundred six (49%) satisfactorily completed the questionnaire. One patient was mentally handicapped and was unable to complete the questionnaire. Of the 107 patients, 82 (77%) were satisfied with the device and 92% were using the device regularly. On average, patients reported using the device 10.1 h/d, 5.6 d/wk. Patients scored their satisfaction rates under different conditions as seen in Tables 7 and 8. DISCUSSION Since its introduction in 1977, the Baha system has been enjoying wider recognition and added applications. It was first introduced to replace bone vibration devices for patients unable to use air conduction hearing aids, such as in cases of mastoid cavities, recurrent otorrhea, congenital aural atresia, etc (4). The newer application, for use as a method for transcranial routing of signal, in
TABLE 6.
Complication Hypertrophic scar requiring excision/flap revision Fixture extrusion/failure to osseointegrate

cases of single-sided deafness, such as acoustic neuroma, ` sudden sensorineural hearing loss, Menieres disease, and others, was introduced in 2002 (5). The heightened interest in this device, generated by the broadened indications, has created a surge in the number of surgeons performing the procedure, with at times, a higher incidence of complications. Complications in Baha surgery are divided into two main categories: bone and soft tissue. The two categories are not completely separate, however, because extended soft tissue complications can result in the loss of the implant. Bone complications essentially result in failure to osseointegrate, or delayed Bdisintegration[ resulting in the loss of the implant. In a review of 214 patients, Reyes et al. (6) reported loss of integration in 11 patients (5%). House and Kutz (7) reported implant extrusion in 5 (3.4%) of 149 patients. Children have a higher incidence of extrusion as reported by Proops (10.1%) (8) and Lloyd et al. (26%) (9). In an analysis of their implant failures (11.2%), Zeitoun et al. (10) reported that the only factors identified as contributors to the fixture loss were trauma and incomplete insertion. Our implant loss rate of 1.3% is extremely encouraging. Our only losses to date have been in children. One 9-year-old boy never integrated, and the fixture was loose on exposure to exteriorize it at the second stage, 6 months later. The child was reimplanted successfully, and analysis of the lost fixture failed to reveal the cause
TABLE 8. Situational patient satisfaction: how satisfied are you with the device (scale 1Y10)
Questionnaire item 4. One individual/ quiet situation 5. One individual/ in a crowd 6. Music 7. TV/radio 8. At a dinner table 9. Aesthetics 10. Handling 11. Sound localization 12. Overall device satisfaction SSD (n = 61) 7.7 5.2 7 7 5.8 6.5 8.2 5 6.9 CHL (n = 45) 8.2 6.3 7.7 7.5 7 7.4 8.5 6.7 8 Overall (n = 106) 7.9 5.7 7.3 7.2 6.3 6.9 8.3 5.7 7.3

Complications requiring revision surgery in 223 implanted ears

n 10 3 % 4.5 1.3

SSD indicates single sided deafness; CHL, conductive/mixed hearing loss. Otology & Neurotology, Vol. 00, No. 00, 2008

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TABLE 9.
Grade 0 1 2 3 4 5

J. J. WAZEN ET AL.
Proposed soft tissue reaction grading scale
Clinical description No irritation: epithelial debris removed if present. Slight redness: temporary local treatment indicated. Red and slightly moist; no granulation tissue present. Red and moist with granulation tissue, skin overgrowth, or scar formation: Local treatment indicated. Extensive granulation, skin overgrowth, or scar formation requiring revision surgery. Removal of skin-penetrating abutment necessary to control infection.

of nonintegration. Another child, age 14, implanted using a one-stage procedure, never integrated and had to be reimplanted. A third child, age 10, lost fixture approximately 1 year after successfully using the processor. Trauma and infection are presumed to be the cause. We think that our success rate in fixture retention is based on precise surgical technique of inserting the implant atraumatically, with copious irrigation. The implant is never touched by nontitanium instruments, gloves, or towels and is placed in solid bone away from air cells. A 4-mm implant is used whenever possible, even if dura is encountered and must be slightly indented. The rate of soft tissue complications varies across the literature. Lustig et al. (2) reported a 7.5% rate of significant skin reactions. Shirazi et al. (11) reported a 10% incidence of partial or complete loss of the skin graft. The rate of complications in any procedure is dependent on the surgical technique, the surgeons experience as well as patient-related factors. Tjellstrom et al. reported a decrease in the frequency of adverse skin reactions from 6.8% in their first 60 patients to 3.5% in 149 patients, implanted 10 years later (12,13), due to refined techniques in handling of the soft tissue. Our rate of significant skin reactions requiring revision surgery was 4.5%, with partial loss of the edge of the graft in two patients. Proper handling of the soft tissue is a key feature in the surgical success of the Baha system. Since 1985, we have implemented multiple changes in the soft tissue component of this surgery. Early on, we excised a circle of skin around the abutment and replaced it with a full-thickness skin graft from the postauricular sulcus. The technique was then modified to raising a semicircular flap around the abutment, with thinning of the flap and manual excision of the hair follicles. This technique saved us time acquiring the full-thickness skin graft and closing the donor site. We have learned in time that thin, hair-free, and immobile skin around the abutment yields better healing, with a reduced rate of postoperative periabutment skin inflammation. The introduction of the Baha dermatome in 2001 helped us standardize our skin flap to a 0.6-mm thickness and 25-mm width. Such flap thickness ensures elimination of all the hair follicles. Great care must be taken to preserve the periosteum, except at the implant site, for proper flap survival. It is also of significant importance to perform wide subcutaneous tissue thinning beyond the flap edges
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to ensure gradual sloping of the skin toward the implant site. The extent of the subcutaneous tissue thinning depends on the thickness of the patients scalp. A minimum of 1.5 cm beyond the edges of the 25-mm flap is recommended. Thicker scalps require wider subcutaneous tissue thinning. In an effort to standardize reporting of the soft tissue postoperative reactions, we attempted to use the grading system of Holgers et al. (12). However, we found the system to be slightly incomplete, because there were patients who developed granulation tissue, hypertrophic scars, or keloids but were successfully treated in the office with no need for revision surgery. We therefore would like to introduce a modification to the grading system, as seen in Table 9, that includes an additional grade for patients with granulation tissue, skin overgrowth, or keloid formation, who do not require revision surgery. Standardizing the reporting will help in comparing series and in using the results of different series in metaanalyses and other statistical evaluations. Following a closely monitored healing phase, we have been attaching the processor at 6 weeks postoperatively. A pilot study on the waiting time for Baha loading revealed no increased extrusion rate for patients with implants loaded 6 weeks postoperatively compared to those loaded 3 months postoperatively (14). All adult patients implanted by the senior author since 2002 have received their processor at 6 weeks with no implant losses. Most patients have been very happy, enjoying the Baha use at this earlier interval, rather than waiting for 3 months. Patient satisfaction was measured using questionnaires. Both subgroups, patients with conductive losses as well as those with single-sided sensorineural losses, reported equal satisfaction with enhancement of their quality of life with the Baha system. Ninety-two percent (92%) of the patients are using the device for a mean of 10 h/d, 5.6 d/wk. Many patients have expressed wishes for a smaller, stronger device, and a longer battery life. Successful Baha implantation is dependent on wellestablished bone and soft tissue techniques. While surgical techniques continuously evolve, it is imperative that surgeons do not disregard the basic principles that led them to where they are now. New surgeons are encouraged to take didactic and hands-on courses as well as observe experienced surgeons to sharpen their surgical technique and reduce the chances of complications.

CONCLUSION The Baha system is safe and effective in the rehabilitation of patients with conductive, mixed, and single-sided sensorineural hearing losses. Key features in maximizing success and minimizing complications are as follows: - Proper patient selection - Accurate location of the implant - Strict handling of the implant - Creating a thin, hairless, immobile flap

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SUCCESSES AND COMPLICATIONS OF THE BAHA SYSTEM - Generous wide subcutaneous tissue thinning - Learning the technique through hands-on courses and live surgical observations
Acknowledgments: The authors wish to thank Joseph Wazen and Lacie McPeek who assisted with data collection.

7. 8. 9. 10.

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