Surgical and audiological outcomes of a fully implantable middle ear implant: early results from a retrospective multicentre study.

PURPOSE: This paper reports the surgical and audiological outcomes of a large series of patients who received a fully implantable middle ear implant (MEI): carina (Cochlear, Australia). METHODS: This is a multicentre retrospective study involving three tertiary referral centres. Patient data were collected for the first 42 consecutive patients who were fitted with the MEI between 2014 and 2019 (Sheffield from February 2017 to January 2019; São Paulo from April 2015 to September 2017; Porto from December 2014 to May 2017). The main outcome measures included surgical results, free field speech testing with speech recognition thresholds (SRT) and audiological gain. RESULTS: There was one major complication due to infection resulting in a brain abscess and explantation of the device. Three other patients had minor skin infections; no other complications were reported. Results show a functional gain of 19.5 dB (p < 0.05) with the MEI versus unaided condition. SRT improved from 57.4 dB to 44.6 dB with the MEI (p < 0.05). CONCLUSIONS: This fully implanable active MEI offers a reliable option for patients with moderate-to-severe sensorineural or mixed hearing losses especially for those do not tolerate or cannot use conventional hearing aids. It provides significant improvement in hearing as shown in the audiological outcomes. The surgery is relatively straightforward but there is a steep learning curve. The devices are well tolerated by all patients.

First United Kingdom experience of the novel Osia active transcutaneous piezoelectric bone conduction implant.

PURPOSE: Bone conduction hearing devices are widely used and indicated in cases of conductive, mixed or single-sided deafness where the conventional hearing aids are not indicated or tolerated. This prospective study aims to investigate the surgical and hearing outcomes of a novel active piezoelectric transcutaneous bone conduction device (t-BCD). METHODS: Prospective data were collected from the first 10 patients who underwent implantation with the t-BCD Osia (Cochlear, Australia) (between Dec 2018 and March 2019) in a tertiary referral centre. The main outcome measures include: surgical outcome, free field speech testing with speech recognition thresholds, audiological gain and patient-reported outcomes including the 'Glasgow Benefit Inventory' (GBI) and the 'Client Oriented Scale of Improvement (COSI). RESULTS: The mean length of surgery was 70.6 min (range 50-87, SD = 9.5). Mean skin thickness measured was 5.6 mm (range 4-8, SD = 1.1). There were two post-operative wound infections which settled conservatively. One required revision surgery to thin skin. The average gain in hearing with the implant was + 39.4 dB. Pre-implantation mean unaided SRT was 38.1 dB (SD = 7.8) and the post-implantation mean-aided SRT was 22.7 dB (SD = 4.6) (p = 0.000078). There was improvement in COSI domains. The mean Glasgow disability score dropped from 52% pre-implantation to 20% post-implantation (p = 0.001). CONCLUSIONS: This new active t-BCHD provides excellent audiological gain and improvement in speech recognition. Patient-reported outcomes have also been very positive. The surgery was straightforward with no major surgical complications reported. Further studies will be required to examine long-term outcomes in larger number of patients.

Reliability and validity of the Italian nose obstruction symptom evaluation (I-NOSE) scale.

The NOSE scale is a questionnaire assessing QOL related with nasal obstruction. The aim of this study was to culturally adapt the NOSE scale into Italian (I-NOSE). Prospective instrument validation study. Cross-cultural adaptation and validation were accomplished. Cronbach α was used to test internal consistency in 116 patients complaining nasal obstruction and 232 asymptomatic subjects. Pearson and ICC tests were used for test-retest reliability analysis. Normative data were gathered from the 232 asymptomatic subjects. Mann-Whitney test was used to compare the I-NOSE scores in patients and asymptomatic subjects and in 40 patients before and after septoplasty. I-NOSE scores obtained in 60 patients were correlated with rhinomanometric results and with the score of a visual analog scale (VAS) measuring the subjective sensation of nasal obstruction. Good internal consistency and good test-retest reliability were found. I-NOSE mean score of the normal cohort was 12.1 ± 13.2. Asymptomatic subjects scored lower than patients with nasal obstruction (p = 0.001). Positive correlations between I-NOSE scores and VAS and rhinomanometric results were found. The mean I-NOSE score improved from 64.4 ± 23.6 to 22.1 ± 13.5 after septoplasty (p < 0.001). The I-NOSE scale is a reliable, valid, self-administered, symptom-specific questionnaire; its application is recommended.