Eur Arch Otorhinolaryngol DOI 10.1007/s00405-015-3688-4

OTOLOGY

Subtotal petrosectomy and CodacsTM: new possibilities in ears with chronic infection Burkard Schwab1 • Eugen Kludt1 • Hannes Maier1 • Thomas Lenarz1 Magnus Teschner1



Received: 3 March 2015 / Accepted: 10 June 2015 Ó Springer-Verlag Berlin Heidelberg 2015

Abstract Subtotal petrosectomy combined with obliteration of the tympanomastoid is a standard procedure to treat temporal bones in patients with radical cavity and chronic infections. Currently, patients with profound-tosevere sensorineural hearing loss are often fitted with cochlear implants. In the case of profound mixed hearing loss, active middle ear implants have been used successfully. The new CodacsTM system provides an effective treatment for patients with severe-to-profound mixed hearing loss; however, only aerated middle ears have been treated with this device. The question arises whether the CodacsTM can be implanted in patients with radical cavity or ears with chronic otorrhea. Of the 41 patients who were implanted with the CodacsTM at the department, 4 received the device after subtotal petrosectomy and obliteration with abdominal fat. Clinical and audiological results were assessed. The device was implanted without any complications in the obliterated subtotal petrosectomy. The preliminary results of the first two patients showed stable bone conduction thresholds and indicated improved speech intelligibility in quiet and noise. Implanting the CodacsTM device after subtotal petrosectomy and obliteration with abdominal fat has been proven to be a feasible and suitable procedure for patients with radical cavity or chronic otorrhea. The speech intelligibility outcome directly after activation was comparable to patients with aerated middle ears.

& Magnus Teschner [email protected] 1

Department of Otolaryngology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany

Keywords CodacsTM  Subtotal petrosectomy  Cochlear implant  Mixed hearing loss  AVIS  AMEI  Chronic infection  Obliteration

Introduction Subtotal petrosectomy (SP) in combination with obliteration of the tympanomastoid cavity has been developed as a standard, safe and secure procedure to treat chronic and recurrent infections of the temporal bone. In this procedure, eradication of all accessible air cell tracts and mucosa in the petrous pyramid followed by obliteration of the eustachian tube and closure of the external auditory canal is performed. The middle ear and mastoid clefts are then filled with abdominal fat [1]. In the case of profound-tosevere sensorineural hearing loss (SNHL), when the indication range of conventional hearing aids is exceeded, this procedure allows the option of a cochlear implant (CI) as a staged procedure in a cavity free of infection [2]. In the case of profound mixed hearing loss (MHL), active middle ear implants (AMEI) have been proven to be a useful procedure and can be implanted several months after subtotal petrosectomy [3, 4]. The new CodacsTM system has been developed to provide an effective new treatment for patients with severe-toprofound MHL. Intended for otosclerosis, these patients can benefit substantially using this device [5]. By coupling the sound energy directly to the perilymph using an artificial incus, this device is reported to provide good audiological results with a mean functional gain of 50 ± 9 dB (0.5–4 kHz) and monosyllabic word scores of 85 % at 65 dB presentation levels, as compared to the 25 % scores of conventional hearing aids. Moreover, average speech intelligibility in noise measured with the Oldenburger

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sentence test (OLSA) (S0N0) improved by 7.1 to 0.3 dB the signal-to-noise ratio (SNR). The mean bone conduction (BC) threshold remained unchanged or showed a minimal increase in the low-frequency range. Thus, this device provides an effective improvement of the speech perception in quiet and noise compared to the best-aided condition in subjects suffering from severe-to-profound MHL [6]. In general, AMEIs provide superior audiological results in mixed hearing loss cases compared to state-of-the art conventional hearing aids [7]. The question is whether the CodacsTM can be implanted in patients who have undergone a subtotal petrosectomy and obliteration with abdominal fat. This approach would lead to new, more successful possibilities to treat patients with severe-to-profound mixed hearing loss and chronic infections of the mastoid. In phantom tissue, the effect of obliteration and embedding the actuator has already been investigated with the actuator output not affected in bench experiments [8]. Thus, this study’s aim was to identify any clinical and surgical limitations and determine the audiological outcome.

tomy. The oval window and round window niche presented in good condition. After removing all aired cells, the cavity was filled with abdominal fat, which was soaked with fibrin glue. The external auditory canal was surgically closed. After 6–14 months, the CodacsTM device was implanted in the standard technique [5] (Fig. 1a, b). The four patients were activated 5–7 weeks after implantation and were fitted over a period of 2 days using the in situ/CodacsTM direct audiogram. To date, two patients completed the follow-up control visit 3 months after the activation. The audiological protocol consisted of air conduction (AC) and BC pure-tone thresholds as well as aided thresholds and the Freiburg monosyllabic test at 65 and 80 dB SPL in sound field with speech coming from the front (S0). Moreover, speech intelligibility in noise with speech and noise coming from the front (S0N0) was measured 3 months after activation using the OLSA at 65 dB SPL noise level and adaptive speech level and the Hochmair–Schulz–Moser (HSM) sentence tests at 65 dB SPL speech level and ?10 dB SNR. All results were analyzed retrospectively.

Material and method Results The study was approved by the representative human institutional review board (approval Nr. 2471-2014). Of the 41 patients who have been implanted with the new CodacsTM device between October 2013 and November 2014, 4 (59–78 years) could be included in this study (one male and three female). For two patients the audiological results 3 months after activation were available. All patients suffered from chronic otitis and underwent a canal wall down procedure in previous surgeries. In all patients, otomicroscopy showed a radical cavity without any signs of current cholesteatoma. Audiologically, all patients had a profound mixed hearing loss. Preoperative pure-tone audiometry (PTA, 0.5, 1, 2, 4 kHz) revealed a conductive part ranging from 26 to 46 dB. The bone conduction (BC) PTA before obliteration was between 41 and 56 dB HL. Measurement of Freiburger monosyllables in speech audiometry through headphones revealed mean word recognition scores (WRS) of 50 % at 80 dB SPL to 25 % at 110 dB SPL. All patients underwent preoperative test with a bone conduction device on headband; however, they presented insufficient results. In all patients, a subtotal petrosectomy, as described by Coker [1], was performed to assess a cavity free of infection. This procedure was performed in preparation of a subsequent AMEI application. In three patients, the stapes suprastructure was not present during subtotal petrosec-

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The device was implanted without any complications in the obliterated subtotal petrosectomy in all four patients. Positioning the device on the mastoid, the artificial incus above the oval window and the stapes prosthesis onto the artificial incus was performed without any restriction caused by the abdominal fat (Fig. 1a, b). Both the oval window and the round window niche presented without any irritation during CodacsTM implantation; likewise the abdominal fat presented without any signs of infection. Postoperatively, no patient suffered from any minor or major complications, including wound dehiscence or infection. AC and BC PTAs were assessed during activation approximately 6 weeks after implantation. The preliminary results showed no major changes in bone conduction thresholds (Fig. 2a, b). The in situ (CodacsTM direct) thresholds could be measured for all frequencies in both patients (Fig. 3a, b). The uncomfortable loudness levels (UCL) of the output could not be reached for frequencies of 6 and 8 kHz in the first patient. The dynamic range of his fitting was between 15 and 30 dB for the frequencies below 6 kHz (Fig. 3a). For the second patient, the dynamic range of the fitting was between 20 and 30 dB (Fig. 3b). The speech intelligibility outcome after 3-month usage of the speech processor is presented in Table 1.

Eur Arch Otorhinolaryngol Fig. 1 CodacsTM implantation in a patient after subtotal petrosectomy and obliteration with abdominal fat. a The abdominal fat (arrow) presents without any signs of inflammation. b The stapes prosthesis fixed on the artificial incus and inserted in the cochleostomy (arrow)

Fig. 2 Pure-tone audiometric data of a patient 1 and b patient 2 showing preoperative, post obliteration and postimplantation outcome. Thresholds were determined by headphones, except aided thresholds in free field (FF)

Fig. 3 In situ/CodacsTM direct audiograms of a patient 1 and b patient 2. Dotted and dashed lines indicate the working range for the Codacs transducer (minimum and maximum output, respectively)

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Eur Arch Otorhinolaryngol Table 1 Speech intelligibility with CodacsTM, 3 month after activation Patient Nr. 1 (female, 78 years)

Freiburg monosyllables

HSM sentence test (%)

OLSA S0N0 (noise 65 dB SPL, speech adaptive)

65 dB SPL: 55 %

80

0.8 dB SNR

58

4.5 dB SNR

80 dB SPL: 85 % Nr. 2 (female, 75 years)

65 dB SPL: 65 % 80 dB SPL: 70 %

The OLSA was conducted at 65 dB SPL noise and adaptive speech level and the HSM sentence tests at 65 dB SPL speech level and ?10 dB SNR

Discussion Subtotal petrosectomy with obliteration with abdominal fat has become a standard procedure and provides long-term stability to allow patients with radical cavity to be implanted with hearing devices such as AMEI [9, 10] or CI [2, 11]. Our results indicate that in line with this, the CodacsTM device offers possibilities for patients with chronic otitis media and radical cavity and profound-tosevere MHL. Both the clinical and the audiological data provide good results. We did not experience any complaints or any major complications, proving this procedure to be suitable, at least in the short term. Implantable hearing devices have been developed as a standard procedure in Europe, reflecting new possibilities for different devices. Over time, various applications have been developed in addition to the standard applications in sensorineural hearing loss to treat patients with abnormal middle ear anatomy. In recent years, artificial vibrating intracochlear stimulation (AVIS) approaches have been developed to treat patients who suffer from moderate-tosevere hearing impairment and cannot be treated with conventional hearing aids. AVIS approaches consist of new methods for inner ear stimulation which create sound transfer to the cochlear fluids by artificially generated vibration. These applications include the ‘‘Power stapes’’, realized by a Vibrant Soundbridge (VSB) attached to the long process of the incus combined with a stapes surgery; the ‘‘Vibrant DACS’’ with the VSB floating mass transducer stimulating the perilymph through the stapes footplate by an oval window coupler; and the CodacsTM, a stapes prosthesis attached to an artificial incus driven by a transducer system [5, 7, 11]. In contrast to conventional hearing aids, which often introduce signal quality loss and feedback, these devices are less prone to these problems. Moreover, in patients with diseased or previously operated middle ears, in which such problems are often exacerbated, these devices have been proved to be suitable [9, 10, 12– 17]. The CodacsTM device is coupled to the perilymph by an artificial incus to provide inner ear stimulation. Several studies have shown that this device is successful in the

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treatment of profound-to-severe sensorineural and combined hearing loss. It is being considered as an effective standard therapy for auditory rehabilitation and improved functional gain at all relevant frequencies. Coupling the device to the perilymph provides consistent results, although mechanical factors might be crucial [5–7]. Audiologically, this procedure presents good results in terms of speech intelligibility. Moreover, the abdominal fat creates no mechanical limitations for the achievable output level. This device and other AMEIs were tested in agar and abdominal fat without significant degradation of the output amplitude [8]. Here, we could show in a clinical application that the CodacsTM has good results at frequencies below 500 Hz and provides good results in speech intelligibility. Clinical results presented no severe complications. No major risk of infection in patients with cochleostomy in subtotal petrosectomy and obliteration with abdominal fat could be detected within the limited observation time. In general, subtotal petrosectomy ensures a cavity free of infection and, after closure of the cavity with abdominal fat, a long-term protection against infections. Many surgeons are reluctant to perforate the footplate to open the perilymph space of the inner ear in potentially infected ears. However, it has been shown that this procedure does not (necessarily) present major risks for the inner ear [2, 11]. Likewise, we did not detect any complications in our current study after implanting the CodacsTM device. Generally, implantation of hearing devices is not associated with major risks of infection, nerve palsy or other clinical complications [18, 19], and consequently the treatment of obliterated ears with the CodacsTM creates new possibilities that may be audiologically superior to existing options.

Conclusion Our results demonstrate that the new implantable hearing device CodacsTM is a feasible option for patients with obliterated radical cavity. Prior implantation of the device, subtotal petrosectomy and obliteration with abdominal fat

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is suitable to achieve a cavity free of infection. Thus, this new method offers possibilities for patients with chronic otitis media and radical cavity in a subsequent step. However, more cases, with longer follow-up are required to determine long-term effects and achievable audiological results. Conflict of interest HM and EK received travel support to conferences by Cochlear Ltd.

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Subtotal petrosectomy and Codacs™: new possibilities in ears with chronic infection.

Subtotal petrosectomy combined with obliteration of the tympanomastoid is a standard procedure to treat temporal bones in patients with radical cavity...
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