Yvette E Smulders 1, Alice van Zon 1, Inge Stegeman 1, Albert B Rinia 2, Gijsbert A Van Zanten 1, Robert J Stokroos 3, Nadia Hendrice 3, Rolien H Free 4, Bert Maat 4, Johan H M Frijns 5, Jeroen J Briaire 5, Emmanuel A M Mylanus 6, Wendy J Huinck 6, Adriana L Smit 1, Vedat Topsakal 1, Rinze A Tange 1, Wilko Grolman 1
JAMA Otolaryngol Head Neck Surg
. 2016 Mar;142(3):249-56. doi: 10.1001/jamaoto.2015.3305.
Accessed: 15th August 2022
Importance: The cost of bilateral cochlear implantation (BCI) is usually not reimbursed by insurance companies because of a lack of well-designed studies reporting the benefits of a second cochlear implant.
Objective: To determine the benefits of simultaneous BCI compared with unilateral cochlear implantation (UCI) in adults with postlingual deafness.
Design, setting, and participants: A multicenter randomized clinical trial was performed. The study occurred in 5 Dutch tertiary referral centres: the University Medical Centers of Utrecht, Maastricht, Groningen, Leiden, and Nijmegen. Forty patients eligible for cochlear implantation met the study criteria and were included from January 12, 2010, through November 2, 2012. The main inclusion criteria were postlingual onset of hearing loss, age of 18 to 70 years, duration of hearing loss of fewer than 20 years, and a marginal hearing aid benefit. Two participants withdrew from the study before implantation. Nineteen participants were randomized to undergo UCI and 19 to undergo BCI.
Interventions: The BCI group received 2 cochlear implants during 1 surgery. The UCI group received 1 cochlear implant.
Main outcomes and measures: The primary outcome was the Utrecht Sentence Test with Adaptive Randomized Roving levels (speech in noise, both presented from straight ahead). Secondary outcomes were consonant-vowel-consonant words in silence, speech-intelligibility test with spatially separated sources (speech in noise from different directions), sound localization, and quality of hearing questionnaires. Before any data were collected, the hypothesis was that the BCI group would perform better on the objective and subjective tests that concerned speech intelligibility in noise and spatial hearing.
Results: Thirty-eight patients were included in the study. Fifteen patients in the BCI group used hearing aids before implantation compared with 19 in the UCI group. Otherwise, there were no significant differences between the groups' baseline characteristics. At 1-year follow-up, there were no significant differences between groups on the Utrecht Sentence Test with Adaptive Randomized Roving levels (9.1 dB, UCI group; 8.2 dB, BCI group; P = .39) or the consonant-vowel-consonant test (median percentage correct score 85.0% in the UCI group and 86.8% in the BCI group; P = .21). The BCI group performed significantly better than the UCI group when the noise came from different directions (median speech reception threshold in noise, 14.4 dB, BCI group; 5.6 dB, BCI group; P <.001). The BCI group was better able to localize sounds (median correct score of 50.0% at 60°, UCI group; 96.7%, BCI group; P <.001). These results were consistent with the patient's self-reported hearing capabilities.
Conclusions and relevance: This randomized clinical trial demonstrates a significant benefit of simultaneous BCI above UCI in daily listening situations for adults with postlingual deafness.